Document Rvw2aDj2xzJneLY3OpX26w1z
Mailer Medical GmbH I Wasserkuppenstr. 29-31 I D-36043 Fulda
To the kind attention of
ECHA, Finland BAuA Division 5, Germany Bureau REACH, RIVM, The Netherlands KEMI, Sweden Norwegian Environment Agency, Norway The Danish Environmental Protection Agency, Denmark
moLLeR
September 12th, 2023
Subject: Reference:
Opposition to the proposed restriction on the manufacture, placing on the market and use of PFASs
Proposed restriction on the manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS) from Feb. 07th, 2023
To whom it may concern
Moller is a manufacturer of several kinds of medical devices as well as devices for fluid management and life science. Our products mainly consist of metal and plastics. Particularly our products for nano coatings and medical devices are highly specialized and often contain PFAS in the form of fluoropolymers. In the following paper we would like to prove how important and irreplaceable these fluoropolymers such as PTFE, FEP or PFA are for our company and hereby object to a general restriction of the entire PFAS group.
Content
1. Analysis of the scope of application
2
2. Hazard or exposure
3
3. Information about alternatives
4
4. Information about costs
7
5. Information about the disadvantage of the restriction
8
6. Transition period
8
7. Exemptions
10
8. Summary, result and claims
11
References
12
A. Attachment I: Product list
13
Moller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Becher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
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mot_LaR
1. Analysis of the scope of application
Our product portfolio covers several areas. Most important for the use of fluoropolymers are Medical De-
vices, In-Vitro Diagnostic devices and products for Fluid Management. Further, we use fluoropolymers in
lubricants. In total we have more than 100 raw materials and articles we purchase to produce more than
200 articles made of or containing fluoropolymers like PTFE, FEP, PFA, ETFE, ECTFE, PVDF, FKM and
FFKM (Please find examples of our prod- Ti I
ucts with fluoropolymers in the blue
I
F
boxes). A variety of production steps are VacStent GITM
necessary to make these articles fit for
the assembly to products, including in-
jection molding, turning, drilling and mill-
ing (not an exhaustive list). The area "Fluid management" uses the most fluoropolymer-articles for HPLC or diagnostic applications. The suitability of fluoropolymers results from their molecular property profile. While coatings, e.g. in the field of in-vitro diagnostics, must have low carry-over in order not to produce incorrect results, which also applies to the entire sample
Insertion hose made of PTFE
VacStent GITM is a patented innovation in endoscopic therapy for leaks because it combines the advantages of the covered stent with those of improving wound healing through vacuum drainage. It has obtained the CE mark as a class 2 A medical device. VacStent GITM targets the clinical problems of perforations and surgical leaks in the gastrointestinal tract (esophagus, stomach, intestine, colon). It consists of a silicone-coated, self-expanding superelastic NiTi stent with a cylindrical polyurethane sponge on the outside, connected via catheter to a vacuum source. For easy insertion into the esophagus the hose is made of PTFE. This material combines perfect gliding properties with biocompatibility and is chemically inert. Injuries to the esophagus are thus minimized. No other material can achieve these advantages.
path in the area of dosing units, the tubing materials must have a certain transparency for the purpose of
liquid detection. In addition, a certain flexibility as well as mechanical stability is required, since the dosing
units are always mobile, with different travel paths. As a material with good sliding properties and low fric-
tional resistance, fluoropolymer coatings also ensure that, for example, septa of sample vessels can be
pierced safely and with the least amount of force, without destroying the barrier between the sample and
the environment. Finally, the materials used must also be resistant to the often highly alkaline and aggres-
sive media (e.g. sodium hydroxide with chlorine bleach) used to clean the diagnostic systems. These prop-
erties also come into play with flanged tubing, washers and sealing rings. When screwed together, the gap
between the fluoropolymer and the counterpart is kept dry by the hydrophobic effect of the fluoropolymer,
which optimally reduces sample carryover and prevents contamination and possible corrosion of the flange
surfaces. In addition, fluoropolymers, like no other material, ensure that the sealing surfaces do not seize
and can still be loosened without any problems even after years. Also due to their water-repellent effect,
fluoropolymers (PVDF, FKM and FFKM) contribute to the hydrostatic sealing of simple connections of nee-
dle and hose fittings. According to the current state of the art known to us, only fluorinated rubbers exhibit
chemical resistance and swelling behavior under static pressure when installed, since other materials often
degrade after a short period of use.
Moller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Becher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
Mgmoeller-medical.com www.moeller-medical.com
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HPLC columns ,,re
A MIIIM
Sealings made of PVDF or PFA
The HPLC (High-performance liquid chromatography) technique is used to separate, identify and quantify each component in a liquid mixture. This liquid passes an adsorbent material within the HPLC column with very high pressure. Due to different behavior of the components of the liquid with the adsorbent it causes different flow levels and this leads to a separation of the components which can be measured. The picture above shows one of our Uberinert HPLC columns with a detailed cross-section on the right side. The sealing is directly injected into the metal part. Because of the high pressure and different kinds of more or less reactive solvents the sealings have to withstand harsh conditions. Additionally the carryover needs to be as low as possible to achieve best accuracy. Only fluoropolymers like PVDF or PFA are used and have the desired properties for this application.
MOLLER
In the field of liquid chromatography (e.g. HPLC), especially when coupled with highly sensitive mass spectrometers, fluoropolymers are superior to all other plastics used. The background noise caused by leaching impurities or dissolved polymer is significantly lower and the "contamination of the system" caused by use by analytes and accompanying substances is almost non-existent when using fluoropolymers such as PTFE and PVDF, which is also used as an inert sealing material in the highpressure area available. An article and product list can be found in Attachment I: Product list.
2. Hazard or exposure
All PFAS used in our products are fluoropolymers which show no acute or subchronic systemic toxicity, irritation, sensitization, local toxicity to implants, genotoxicity (in vitro and in vivo), hemolysis, complement activation, or thrombogenicity. [1] These substances may be persistent in the environment, but persistence alone does not constitute a danger in professional circles. Furthermore fluoropolymers do not permeate into human cells which PFAS are blamed for. The molecules are simply too big and the characteristics are completely different compared to PFAS which are low-molecular substances. [2] Because of their molecular appearance they fulfil the criteria of "polymers of low concern" of the OECD. [3] [4] With that said our fields of applications leave no risk on the human body to resorb or store the fluoropolymer products. Therefore there is no hazard to the human body.
Additionally the hazard or exposure to nature is low to non-existent, as our products are highly specialized and intended only for companies or specialists. Disposal takes place under controlled conditions and it can be assumed that our products will be disposed of in the intended manner.
Moller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Becher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
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IVI (31-I-ER
3. Information about alternatives
Even in the published restriction report, annex XV there is mentioned that there is sufficiently strong evidence that technically and economically feasible alternatives are not available and that there is a low substitution potential at Entry Into Force. [5] Especially for PFAS-articles which must cover a wide range of properties in a product and are therefore highly specialized there will not be a better substitution material. The C-F bonding is one of the strongest in chemistry and therefore the PFAS-molecules like the fluoropolymers are very unreactive. Thus a permanent derogation for fluoropolymers is vital for the continued existence of these products and this market as well as the ability to have a high quality and care standard for people who depend on those products. If alternatives will be discovered in the future they would lead to a reduced functionality of the product which has a severe impact on the safety, manageability, usability and versatility in the health sector. "[...] There is no alternative to fluoropolymers, because [...] not just any material but the best is needed." (Translation from German). [2] For applications which only take advantage of one or two properties of the PFAS it could be possible to find an alternative substance, but every item has to be checked against its field of application in collaboration with suppliers or customers to find out what is important. Often some things do not seem important but they are and the missing property comes up in the lifetime of the product. This process leaves room for failure because of lacking knowledge and nobody wants a failure if a medical device is involved. Only a few articles are already ready for an alternative material, e.g. protective tubings or caps (now made of FEP or PTFE) are most likely replaceable by TPU or TPE or silicone. A study of feasibility has to be carried out of course.
Table 1 below shows a list of the used PFAS at Willer as well as their properties and the worst case scenario when the now used fluoropolymers will be substituted. There is also the opportunity, that no alternatives could be found. In this case whole products have to be discontinued which will lead to a massive loss of sales reductions, not only at Moller but throughout the whole industries which rely on fluoropolymers.
Moller Medical GmbH P.O. Box 1737 I D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Bacher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
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Table 1: Used PFAS at Killer with properties and worst case scenario
Material Properties
Worst case when subsituted
PTFE FEP PFA
Chemical resistance Resistance to heat and low temperature Electrical insulating power Resistance to light, UV and weathering Low coefficient of friction Nonstick property Low dielectric constant Flexibility Low water absorption [6] Chemically inert to a wide range of industrial chemicals and solvents Temperature range: -240 C to +200 C Good electrical properties Low coefficient of friction Stress crack resistance Outdoor weathering resistance
[7] Chemically inert Exceptional dielectric insulation properties Negligible moisture absorption Low coefficient of friction Non-stick surfaces Excellent weather resistance [8]
Cell content confidential Cell content confidential Cell content confidential
moi_t_aR
Worst case when no substitute can be found
Cell content confidential
Cell content confidential
Cell content confidential
Moller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Becher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
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Material Properties
Worst case when subsituted
ETFE ECTFE PVDF
Chemical resistance Resistance to extremes of temperature Good mechanical strength Low smoke and flame characteristics Odorless Non-toxic Resistance to weather and aging Excellent dielectric properties Radiation resistance [9] Stronger and stiffer than many other fluoropolymers with high impact strength Excellent electrical properties Abrasion, chemical, and weather resistant Exceptionally smooth surfaces Low levels of metallic and organic extractables Excellent fire resistance [10] Low melting point High heat deflection temperature Low permeability Low impact strength, good other mechanical properties Chemical resistance Non-flammable Can be dissolved in organic solvents High dielectric constant Piezoelectric and pyroelectric behavior [11]
Cell content confidential Cell content confidential Cell content confidential
moi_t_aR
Worst case when no substitute can be found
Cell content confidential
Cell content confidential
Cell content confidential
Moller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Becher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
@moeller-medical.com www.moeller-medical.com
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Material Properties
Worst case when subsituted
FKM FFKM
Excellent temperature resistance High chemical stability Good weather, aging and oxygen stability Excellent resistance in mineral oils and fats Low gas permeability Very good resistance in nonpolar media Temperature range from -55 C to +250 C [12] High stability in aggressive media Highly stable in polar and nonpolar media High reliability for dynamic applications High reliability for static applications Temperature range from -30 C to +325 C [13]
Cell content confidential Cell content confidential
IVIOLLER Worst case when no substitute can be found
Cell content confidential
Cell content confidential
4. Information about costs
Product reformulation costs can range from tens of thousands of euros to millions of euros for any single formulation. Product reformulation will also imply costs relating to quality assurance. Loss of functionality of products in this sector could have substantial economic implications, including shorter operational lifetime of components, increased frequency and costs of maintenance, and increased operational downtimes. The costs of substitution are likely to be borne in full (in the form of reduced producer surplus/profits) by the firms active in the sector. [5, p. 115] As described above the search for and implementation of alternative materials involves a lot of steps and is very time consuming.
- At first there has to be clarified which article needs which properties to fulfil its function. Every single article has to be discussed with more than 45 suppliers and 156 customers. [1-2yr]
- If there are no alternative materials for PFAS, new materials have to be developed. [5yrs]
Moller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Becher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
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moLLeR
- Of course the replacement materials must be harmless and non-hazardous and must have no potential to be included to the lists of REACH, POP, MDR,... Long term-effects are hard to anticipate and need to be verified over time [5yrs and longer].
- If alternative materials do not fit 100%, products must be revised or newly developed an the basis of the permitted materials. [>5yrs]
- The altered or new products need to be introduced and validated. The biocompatibility needs to be tested and confirmed. [1yr]
- At the end of this process the altered or new products must be checked against a current approval or must be newly approved by the respective authority of every country. [3yrs]
According to those estimated times on the basis of long year expertise the man hours as well as the associated costs can be estimated. Additionally to the described processes there are collateral procedures which have to be performed, e.g. contracts with more than suppliers and more than customers must be checked and reviewed. Depending on the scope and the purchased/sold products this is also a very time consuming task and difficult to state an estimate. The costs are hardly to estimate but will surely go into millions considering how many departments and people are involved over this long time period. More clearly are the costs when it comes to products. In 2022 the percentage of products with fluoropolymers at Maier was about .% of the turnover [14]. With that said it will affect different products from different product areas at Maier and products will simply vanish from the market. Transferring the implementation of the restriction to the people working at Maier it would lead to a loss of more than jobs if no alternatives could be found.
5. Information about the disadvantage of the restriction
Fluoropolymers are used throughout the whole health sector because of the benefits as described above. This sector with its medical products are a key industry and in Europe and have great influence on other sectors as well.
A restriction of fluoropolymers would most likely lead to a degradation of the product quality and economics in all sectors if inferior alternative materials were used.
6. Transition period
There are several transition periods mentioned, especially for medical devices: Up to 12-year derogation for implantable medical devices and consideration for 12-year derogation of wound treatment products & hernia meshes. [5]
Moller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Becher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
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MLLER
As described within chapter 4: Information about costs, a change of medical products which are distributed throughout the whole world is a very complex and time consuming process which is not dependent on our company alone but involves several parties like many suppliers, customers, regulation authorities and so on. The most time consuming process is the search for alternative materials which are not yet invented and developed, because in some products the versatile properties of the PFAS are needed. The development of new materials takes decades if they can be found at all. Even with existing materials it can take more than 15 years to have an altered product ready for the market. That is why the proposed transition period of 12 years is too short for long-term runners and unacceptable for non-replaceable materials. Furthermore there are questions about what happens after the transition period.
- Is it allowed for end users to use products with PFAS? - Because spare-components are treated as new parts it is not possible to repair products using
PFAS-spare-components. So they result in scrapping. Is that intentional?
Moller Medical GmbH P.O. Box 1737 I D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Becher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
a@moeller-medical.com www.moeller-medical.com
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MOLLER
7. Exemptions
The proposal speaks about the restriction of the complete group of PFAS, but fluoropolymers should not be treated as PFAS as their structure as well as their behavior and properties are different to low molecular weight PFAS. Fluoropolymers on the opposite are high-molecular plastics and classified as "polymers of low concern". That means they are chemically stable, non-toxic, not bioavailable, not water-soluble and not mobile. [15] Further properties and the differentiation between low molecular weight PFAS and fluoropolymers are shown in Figure 1. Because there is no danger compared to other PFAS and the high time- and cost effort which comes with that restriction, fluoropolymers should be exempted from the proposal.
Toxic X Persistent X Bio-accumulative X
Mobile X Water Soluble X
Low molecular weight PFA
Fluoropolymers
High Molecular Weight Macromolecules
Bioinert Thermostable hemically Inert I
UV Stable ly Resilient ging Stable I
PLC Cross-overI
Resistance
Figure 1: Two main families ofPFASs [4J
The study ,,Alternative materials for Fluoropolymers" (Industrieverband Halbzeuge and Konsumprodukte aus Kunststoff e.V. (Industry Association for Semi-finished and Consumer Products made of Plastics)) supports that and concludes the following (translated from German): - Since fluoropolymers have the strongest chemical bond in organic chemistry with the -C-F bond, the
advantage of this "class winner" must be lost if alternative materials are used. - When alternative materials are used, either the function, the safety in the application, or the range of
properties as an overall package is lost - In almost all of the 21 applications analyzed, the PLC status (polymers of low concern) was also lost
when alternative materials were used.
Moller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Bacher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
M@moeller-medical.com www.moeller-medical.com
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Viol- I- ER
8. Summary, result and claims
In principle, it is right to regulate and/or ban substances with harmful properties. A lot of PFAS are in this category and must be regulated, so that they cannot affect the environment or humans and animals. Restrictions and rules must be imposed for proper manufacturing and recycling for those relevant products without alternatives. However, a distinction must be made and not a blanket ban on this entire group of substances because it is easier. We claim: The harmless fluoropolymers should be handled as a group of its own because of their classification as "polymers of low concern" and their irreplaceable functions and properties as and in products. This group must be excluded from the restriction. Otherwise products will be worse with regard to usability, patient friendliness,... or will cease to exist. Then people who are dependent on these products will suffer and the quality of care for patients and for the whole medical division will deteriorate. Next to that complete industries will vanish and people will lose their jobs. This scenario is not far away and we hope it will not become reality.
Contributors: Dr. Mario Gatterdam, Chemical scientist, Product manager Fluid Management, Moller Medical Angela Kikowatz, Head of Quality and Regulatory Affairs, Moller Medical
With best regards
Dr. Andreas Bacher Managing Director
Bj0rn Kreller Quality and Material Compliance Engineer
Moller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Bacher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
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References
MLLER
[1] B. J. Henry, J. P. Carlin, J. A. Hammerschmidt, C. R. Buck, W. L. Buxton, H. Fiedler, J. Seed and O. Hernandez, "A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers," Integrated Environmental Assessment and Management., vol. 14, pp. 316-334, 2018.
[2] Kunststoffe, "Interview mit pro-K Hauptgeschftsfhrer Ralf Olsen: "Fluorpolymere mssen raus aus dem Verbot"," no. 4/2023, p. 14ff, 04 2023.
[3] Organisation for Economic Co-operation and Development (OECD), "Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern," 2009.
[4] B. Ameduri, "ScienceDirect, Journal of Flourine Chemistry, Volume 267, 110117, ISSN 0022-1139," 04 2023. [Online]. Available: https://doi.org/10.1016/j.jfluchem.2023.110117. [Accessed 28 04 2023].
[5] BAuA, RIVM, KEMI, Norwegian Environment Agency, The Danish Environmental Protection Agency, "ANNEX XV RESTRICTION REPORT -- Per- and polyfluoroalkyl substances (PFASs)," Helsinki, Finland, 2023.
[6] "Omnexus - The material selection platform," [Online]. Available: https://omnexus.specialchem.com/selectionguide/polytetrafluoroethylene-ptfe-fluoropolymer. [Accessed 05 06 2023].
[7] "Curbell Plastics," [Online]. Available: https://www.curbellplastics.com/materials/plastics/fep/. [Accessed 05 06 2023].
[8] "Curbell Plastics," [Online]. Available: https://www.curbellplastics.com/materials/plastics/pfa/. [Accessed 05 06 2023].
[9] "Omnexus - The material selection platform," [Online]. Available: https://omnexus.specialchem.com/selection-guide/ethylenetetrafluoroethylene-etfe-plastic. [Accessed 05 06 2023].
[10] "Curbell Plastics," [Online]. Available: https://www.curbellplastics.com/materials/plastics/ectfe/. [Accessed 05 06 2023].
[11] "Omnexus - The material selection platform," [Online]. Available: https://omnexus.specialchem.com/selectionguide/polyvinylidene-fluoride-pvdf-plastic. [Accessed 05 06 2023].
[12] "Polycomp," [Online]. Available: https://www.polycomp.nl/compound/high-performance/fkm/. [Accessed 05 06 2023].
[13] "Polycomp," [Online]. Available: https://www.polycomp.nl/compound/high-performance/ffkm/. [Accessed 05 06 2023].
[14] B. Kreller and A. Kikowatz, "Socio-Economic Analysis at Mller," 2023.
[15] Dr. Mirjam Merz, "PFAS-Beschrnkung, Bewertung des Beschrnkungsvorschlages," Bundesverband der Deutschen Industrie e.V. (BDI), Berlin, 2023.
Mller Medical GmbH P.O. Box 1737 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Becher HRB 5504 Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
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A. Attachment I: Product list
Ml_LER
Material no. 00003678-M01 00003735-N01 60000641LW3NSCTF 61001067-V1 61001067-V2 55-1089 55-1068 52-1041 52-1040 55-1035 55-1031 00000126 00000250 00000458 2 600 003 00000639 00000942 1 500 513 00001430 00001477 00001591 00001856 00001888 00001949 00002122
00002474
00003020 00003119 00003250 00003342 00003376 00003395 00003555 00003670
00003671 00003678 00003735 00003800 00003820 00003831 00004007
00004010 00004018 00004019 00004023 00004225 00004230 00004241 00004289 00004309 00004316 00004317 00004356 00004361 00004394 00004438 20000748
Material name Schlauchpumpe SPQ-225 Qiona Pump Legacy Wave 3 Nadel Set Cobas AmpliPrep Sample Arm Needle var01 Sample Arm Needle var02 Cross Connector Driver Torque T-Handle 100 IN LBS Trial Rod, 200mm Trial Rod, 90mm Mono-Axial Screw Driver Ratcheting Tee-Handle Schlauchpumpe SPQ-072 Doppelkonus 3 x 18 mm HPLC Kartusche 30-4 Distanzscheibe fr Shark Cage Rohr BN 2 Dichtungsteil 5 fr WF2 Distanzscheibe zu 790.100.000.001 Schlauchpumpe SPQ 095 Elektrode Dialysepumpe kpl. PFA-Scheibe 3mm ROD M 5,5 x 0,5 Zahnrad Verschluteller gro mit Schlitz F2041 FoNadel Cerofix Mono T.32.1 0 0,75 PFA-Scheibe Koppler 3mm ROD 4 Bohrungen Rotor 8x12 Dialog+ PFA-Dichtring fr Rack 3mm ROD Verschlussteller kl. Spritzgussvariante Sterisart VIII Basic kpl. verpackt Rotor 7x10 Dialog+ Blutpumpe Dialog+ kpl. CiCa-Rotor Verschlussteller klein m. Schlitz 5,6
mm
Verschlussteller klein ohne Schlitz Schlauchpumpe SPQ-225 Ablationspumpe Qiona II kpl. verp. Schlauchpumpe SPQ-095 VacStent GITM Verschluteller kl.o.Schlitz,geschliffen Tubing Pump Multi Speed Basis Module Dichtring/ RTS Device 500 Rotor SPQ-105 Rotor SPQ-105 - H Vibrasat Pro Accessory Schlauchpumpe SPQ-105 VacStent GITM XMHG0395R-1 Nullserie Mistral Base Unit Schlauchpumpe SPQ-225 Rotor 7x10 Rotor 8x12 Schlauchpumpe SPQ-095 Schlauchpumpe SPQ225 Rotor kpl. 7x10 Rotor 7 x 10 R/L Innensule gespritzt
Material no. 20001111 20003454 20003533 20003534 20003861 20004140 20004786 20012557 20015234 30000006 30000568 30000647 30001047 30002979
30003645 30003681 30003859 30003894 30004388 30004445 30004506 30004725
30005722 30005966 30007092
40000522 50000557 50001651 50001776 50002429 60000192
60000193
60000589 60000685 60000749
60000776 60000788 60000789 60000790 60000791 60000794
60000889 60001024 60001171 60001183 61000361 61000362 61000515
61000527 61000614 61000701
61000726 61000727
Material name Motor vorm. *REP* Schlauchanschlustck Befestigungshalter Deckel
Scheibe LK 0,5 Schutzhlle Rotor kpl. Schutzschlauch f. Cap Piercing Nadel Rotor Schlauchfhrung Netzeingangsfilter Magnet Secolit 315 Netzkabel Typ EU 1,0 PE-Schaumstoff-Verpackung DOCONBlutwaag Schlauch PTFE HN 1331 Schlauch PTFE natur LiquoGuard 7 DEMO MATERIAL Halter SMART-CASE L Radial-Wellendichtring TRK 10-14-3 Magnet Secolit 215 Umkarton Qiona Docon Netzkabel mit Schweizer Stecker Lithium Ion Battery Pack S Gebrauchsanweisung beachten Super FlangelessTM Ferrule w/SST Ring
Messingscheibe (Beistellung) Farbgranulat 5% schwarz PVDF/Solef 6008/0001 Schlauch Schlauch Entstopfungstool fr Tubing 718.82217 E Entstopfungstool fr Tubing 718.81376 C FEP Tube 3,2/1,6 Muster-Schlauch-PVDF
***MUSTER***Innen-Liquide-Schlauch SPOLV Standard Fllnadelgrundkrper Standard Fllnadelgrundkrper Standard Fllnadelgrundkrper Fllnadelgrundkrper Rohteil CIP Drosselrohrling Dms 4 auf 0,0 ***MUSTER ***NEEDLE ASSY 1/428UNF Schraubkappe Muster GRIPPERS FOR 1/8" OD TUBING Schlauch Versilon FEP 4.00x 6.00 natural Wash needle Wash needle Dispensing needle 10 0,40 reduziert/Nano Pipettiernadel Pipette 3001(D0,6-D1,5) SF-TIP Vorstechnadel ID 0,9 Nanoinjektion WPS Kapillarrohr 0,79x0,13x150mm Viper Kapillarrohr 0,79x0,12x250mm Viper
Mller Medical GmbH P.O. Box 1737 1 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Bacher HRB 5504 I Local Court Fulda UST-ID-Nr. DE 112 412 704
M@moeller-medical.com www.moeller-medical.com
Page 13 1 16
Sparkasse Fulda I BIC HELA DE Fl FDS I IBAN: DE19 5305 0180 0040 0144 03 Hypo Vereinsbank I BIC HYVE DE MM430 I IBAN: DE41 5032 0191 0008 6002 28 Commerzbank Fulda I BIC DRESDEFF530 IBAN DE62 5308 0030 0801 6008 00
MOLLER
Material no. 61000728 61000729 61000730 61000731 61000732 61000733 61000734 61000754 61000756 61000757 61000760 61000761 61000762 61000763 61000914 61001060 61001068 61001110 61001136 61001139 61001268 61001372
61001379
61001426 61001449
62000150 62000208 62000219
62000238 62000242
62000250 62000279
62000293 62000318 62000342 62000369 62000377 62000391 62000392 62000398 62000410 62000421
62000429 62000432
62000433
62000434
62000440 62000441
62000442 63000001 63000021 63000023 63000033 63000065
Material name Ka illarrohr 0,79x0,12x350mm Vi er Kapillarrohr 0,79x0,13x450mm Viper Kapillarrohr 0,79x0,13x550mm Viper Kapillarrohr 0,79x0,18x250mm Viper Kapillarrohr 0,79x0,18x350mm Viper Kapillarrohr 0,79x0,18x450mm Viper Kapillarrohr 0,79x0,18x550mm Viper Kapillarrohr 0,79x0,18x150mm Viper Kapillarrohr 0,79x0,12x650mm Viper Kapillarrohr 0,79x0,13x750mm Viper Kapillarrohr 0,79x0,18x65mm Viper Kapillarrohr 0,79x0,18x750mm Viper Kapillarrohr 0,79x0,18x850mm Viper Ka illarrohr 0,79x0,18x950mm Vi er NEEDLE PROBE ASSY SAMPLE Kapillarrohr 0,79x0,13x100mm Viper Reagent Arm Needle Nadel Coatron A6 Plus Kapillarrohr 0,79 x 0,18 x 200 mm Kapillarrohr 0,79x0,18x300mm Viper Dispensing Needle NEEDLE FITTING ASSEMBLY ORING NEEDLE FITTING ASSEMBLY ORING Sample Tip c111 nanoskin 96A Dispensing needle 10 0,40 reduziert/Nano Absaugnadel komplett LIA XL Absaugnadel Wascher Melias Reagenziennadel Melias / FEPFluoroEtch ASSY NEEDLE "'MUSTER"' Absaugnadel ohne Schlitz Aspiration Probe kpl. AMP NADEL M.SEP.DRUCKSCHLAUCH NEEDLE ASSY 1/4-28UNF kpl. Oil Dispense Needle ASSY Needle RSG MIXER IMPELLER INSEP ASSY HYDRA REAGENT PROBE ASSY TIA REAGENT PROBE ASSY SP PROBE ASSY REAGENT ASSY Needle RSG "'UNGEATZT*** PrintNeedle_kpl AIGUILLE PERCAGE ACR FPS EQUIPEE 505121 MQ next gen Cannula 2,0 mm ASM IA REAGENT PROBE ASSY (V1 Spring) IA REAGENT PROBE ASSY (V2 - Silicon) IA REAGENT PROBE ASSY (V3 Heat Shrink IA REAGENT PROBE ASSY AIGUILLE PERCAGE AER FPS EQUIPEE 999P022 HYDRA REAGENT PROBE ASSY Tubingwendel kpl. Probentubing kpl. Pipettor Reagenz ASSM Pipettiernadel kpl.beheizt APACT-AS Stahlkanule mit Kupferrohr kpl.
Material no. 63000071 63000088 64000118 64000280 64000297
64000352 64000353 64000354 64000355 64000360 64000361 64000363 64000364 66000005 66000006 66000007 67000082 67000106 67000122 67000268
67000269
67000270 67000275 67000281
67000282 67000283 67000284 67000285 67000287
67000289 67000292
67000305
67000306
67000307 67000312 67000313 67000314 67000315
67000316 67000317 67000318
67000320
67000321 67000331
67000332
67000334
67000339
67000341
67000376
Material name NEEDLE PROBE ASSY REAGENT CHAMBER PEROX Injektorhalter Insert FM2_FIT_P1_BAR_CON ADAPTOR 1/2 IN BARB - 3/16 IN TUBE O-ring O-ring O-ring O-ring O-ring O-ring O-ring O-ring Spulschuh.kpl.Dop.rechts Spulschuh.kpl.Dop.links Spulschuh.kpl.Einzel Systemschlauch / Esterline SIP TUBE ASSY (CKK) Schlauchsatz TA Dispense WDP 1-5 TUBE ASSY-GRIPPER WASH SUPPLY TUBE ASSY-CC DIL.BLEACH DELIVERY TUBE ASSY-BASIN FILL SUPPLY TUBE ASSY WASH2 PUMP TO WD TUBE BUNDLE ASSY-W-COLLAR LUMO VAC TUBE BUNDLE IMT MANIFOLD TUBE BUNDLE ASSY VENTLINE RH TUBE BUNDLE ASSY IMT FLUIDS TUBE BUNDLE ASSY VENTLINE LH TUBE ASSY-H20 LOOP-IA WASH SEP TUBE ASSY-WASH LOOP-IA WASH TUBE ASSY ARM METERING SUPPLY TUBE ASSY-SALINE PUMP TO ARM BKHD TUBE ASSY-CC DIL. BLEACH TO PUMP TUBE ASSY- SUBRESERVIOR TUBE ASSY METERING PROBE-ARM TUBE ASSY SALINE-DILUTER-ARM TUBE ASSY PROBE-DILUTER ARM TUBE BUNDLE ASSY-IA FLUIDS SUPPLY TUBE BUNDLE ASSY - WB1 SUPPLY TUBE BUNDLE ASSY - WB2 SUPPLY TUBE ASSY WASH2 PUMP TO WD2 MAN-WSH TUBE ASSY BULKFL CH STA 5 WASH 2 TUBE ASSY VALVE TO MANIFOLD TUBE ASSY MEASURE MANF TO IMT UUT TUBE ASSY HALF UNION TO UNFALT REP TUBING ETFE 1.58ID 3.18OD-INLET FILTER-A TUBE ASSY - SINGLE TUBE HEATER PLUNGER TO SENSOR TUBING ASSY Assy TBG Reservoir 400/650ML
Moller Medical GmbH P.O. Box 1737 I D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Bacher HRB 5504 I Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
Page 14 1 16
Sparkasse Fulda I BIC HELA DE Fl FDS I IBAN: DE19 5305 0180 0040 0144 03 Hypo Vereinsbank I BIC HYVE DE MM430 I IBAN: DE41 5032 0191 0008 6002 28 Commerzbank Fulda I BIC DRESDEFF530 IBAN DE62 5308 0030 0801 6008 00
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Material no. 67000558
67000559 67000560
67000561 67000562
67000563
67000564 67000565
67000566
67000567
67000568
67000569
67000570
67000571 67000572 67000573 67000574 67000575
67000576 67000577
67000578 67000579 67000580
67000581 67000582
67000592 67000593
67000595
67000596
67000607
67000608 67000609 67000610 67000616
67000617
68000477 68000478 68000479 68000485
Material name TUBE ASSY SUPPLY WASH SOLUTION TUBE ASSY SUPPLY CONDITIONER TUBE ASSY MANF R-5D TO HTR CW5 ASSY TUBING RESERVOIR 400 ML TUBE ASSY BULK FLUID CC STATION B TUBE ASSY BULK FLUID CC STATION D TUBE ASSY 70MM 1/4-28 TO 1/4-28 TUBE ASSY JUMPER MANIFOLDPERIPUMP TUBE ASSY STANDARD A PUMPMANIFOLD TUBE ASSY SALT BRIDGE GROUND BLOCK TUBE HARNESS ASSY SYSTEM FLUIDS IMT TUBE ASSY BULK FLUID CC STATION A TUBE ASSY BULK FLUID CC STATION E TUBE ASSY BULK FLUID CC VENT A TUBE ASSY - PROBE CLEAN TUBE ASSY - PROBE CLEAN WASH TUBE ASSY BULK FLUID CC VENT B TUBE ASSY DILUENT PUMPMANFLD TUBE ASSY SALINE PUMP SUPPLY TUBE ASSY REAGENT WASH UNIT SUPPLY TUBE ASSY BULK FLUID CC VENT D TUBE ASSY BULK FLUID CC VENT E TUBE ASSY MANF R-4D TO HTR CW4 TUBE ASSY BAISIN FILL TUBE HARNESS ASSY SYSTEM FLUIDS IMT (TG) TUBE ASSY BULKFL IM STA 8 WASH TUBE ASSY-BULKFLUID-IM STA 9CLEANR TUBE ASSY-SALINE-DILUTER-ARMV2 TUBE ASSY MANIFOLD TO PROBEDIL ARM TUBE ASSY BULKFL IM STA ACID BASE TUBE ASSY CC STA TUBE BUNDLE TUBE BUNDLE ASSY VENTLINE LH TUBE BUNDLE ASSY VENTLINE RH TUBING BUNDLE ESSY-MIXER SUPPLY TUBING BUNDLE ASSY-METERING SUPPLY Dichtung 8 mm Mini-Cart Dichtring 10 mm Mini-Cart Dichtring 15 mm Mini-Cart Druckstck RT-LUER M14x1 Mini-Cart
Ml_LER
Material no. 68000486 68000487 68000501 68000502 68000503 68000504 68000519 68000591 68000592 68000720 68000810 68000872 68000992 68001130 68001135
68001185 68001188
68001218 68001219 68001220 68001221 68001228 68001232 68001233 68001363 68001365 68001401 68001504 68001506 68001518 68001572 68001573 68001574 69000320 69000331
69000339 80001515
92004786 92007555 92008216 93002690 93002738 93002979
93003267 93004388 93007722 97000346 790.100.000.078 790.900.000.001 790.900.000.021 790.900.000.022 790.900.000.023 790.900.000.024
Material name Druckstck RT-LUER M16x1 Mini-Cart Druckstck RT-LUER M20x1 Mini-Cart Blindstopfen M8x0,75 Mini-Cart Blindstopfen M14x1 Mini-Cart Blindstopfen M16x1 Mini-Cart Blindstopfen M20x1 Mini-Cart SEALING PLUG 10/32 UNF Kapillarrohr 0 79x0 12x120mm Kapillarrohr 0,79x0,18x120mm Doppelkonus fr 1/16" Kapillare Kapillarrohr 0,5 x 0,2 Kapillarrohr 0.79x0.25x600 Viper Dichtring 8 mm Mini-Cart Dichtring 6,9 mm Capillary PK/ST 0,17x500mm Quick Connect Verschlustopfen 10/32 UNF Capillary PK/ST 0,17x470 Q-Conn Ready HPLC-BIO-SYSTEM HPLC-BIO-SYSTEM HPLC-BIO-SYSTEM HPLC-BIO-SYSTEM Verschlustopfen 10/32 UNF blau 4,6mm HPLC Bio-S stem End Fi 2,1mm HPLC Bio-System End Fi 2,1mm HPLC Bio-System End Fi 2,1mm HPLC Bio-System End Fi ICP Probe 2,1mm HPLC Bio-System End Fi 4,6mm HPLC Bio-System End Fi RT-Cart 50-3 4,6mm HPLC Bio-System End Fi 2,1mm HPLC Bio-S stem End Fi Probe Needle, Single Tube Beschichtet mit TafSkin 103 spray Beschichtung Silikonschlauch nonstick ID Musterbleche, beschichtet Wk-Einsatz V3-Umspritz. Schaft lang c302 Rotor kpl. Doppelschlauchsystem Schlauchset SPQ72G Kabelverschraubung shrinkable tubing PE-Schaumstoff-Verpackung DOCONBlutwaag Federbgel Radial-Wellendichtring TRK 10-14-3 Schrumpfschlauch (PU=20 psc.) Tunap Tungrease 300 Flexible Fhrungshilfe Implantatbox Implantatbox Modul 1 Implantatbox Modul 2 Implantatbox Modul 3 Implantatbox Modul 4
Mller Medical GmbH P.O. Box 1737 1 D-36007 Fulda Phone +49 (0) 661 94195-0 Fax +49 (0) 661 94195-850
Managing Director Marc Stuwe, Dr. Andreas Bacher HRB 5504 I Local Court Fulda UST-ID-Nr. DE 112 412 704
Wmoeller-medical.com www.moeller-medical.com
Page 161 16
Sparkasse Fulda I BIC HELA DE Fl FDS I IBAN: DE19 5305 0180 0040 0144 03 Hypo Vereinsbank I BIC HYVE DE MM430 I IBAN: DE41 5032 0191 0008 6002 28 Commerzbank Fulda I BIC DRESDEFF530 IBAN DE62 5308 0030 0801 6008 00