PALL Posidyne NEO Intravenous Filter

Product definition

Article. These products are not classified as hazardous according to REACH Regulation 1907/2006, or European CLP/GHS Regulation 1272/2008.

Signal word

No signal word.

Hazard statements

No known significant effects or critical hazards.

Special packaging requirements

None. ____________________________________________________________________________________ SECTION 3 - Materials of Construction The filters detailed in Section 1 are comprised of the following materials: Filter assembly (All codes) Material Name CAS Number Modified acrylic copolymer housings Supplier proprietary information Polyamide main membrane Pall proprietary information Black Ink Pall proprietary information Polytetrafluoroethylene (PTFE) vent membrane 9002-84-0 Polyester vent membrane non-woven support 25038-59-9 Set components Material Name Product codes CAS Number DEHP free PVC tubing NEO96E, NEO96NYE, 9002-86-2 NEO96, NEO96NY, 100- 0222 MABS male luer connector 9010-94-0 NEO96NYE, NEO96NY Acrylic male luer connector NEO96E, NEO96, 100- Supplier proprietary 0222 information Co-polyester Female luer connector NEO96E, NEO96NYE, Supplier proprietary NEO96, NEO96NY, 100- information+ 0222 Orange polyethylene copolymer cap on NEO96E, NEO96NYE, 25213-02-9 male luer NEO96, NEO96NY, 100- 0222 Polyethylene copolymer slide clamp NEO96E, NEO96NYE, 25213-02-9 NEO96, NEO96NY, 100- 0222 Polyethylene cap on female luer NEO96NYE, NEO96, 9002-88-4 NEO96NY Acrylonitrile-butadiene-styrene copolymer 9003-56-9 (ABS) cap on female luer NEO96E, 100-0222 Y connector – needle-free access Acrylic – Supplier proprietary information, NEO96NYE, NEO96NY Silicone Rubber – Supplier proprietary information Polyurethane 9009-54-5 These products are not known to contain BADGE, NOGE, or BFDGE. Trace additives will be present in the plastic components. There are no additional ingredients present which, within the current knowledge of the supplier, are classified and contribute to the classification of the article. There are no current SVHC substances known to be present in the finished articles above 0.1%. There are no current ROHS2 Directive (2011/65/EU) and amendment (2015/863) substances of concern (including Lead, Cadmium, Mercury, Hexavalent Chromium, Polybrominated biphenyl (PBB), Polybrominated diphenyl ether (PBDE), Bis(2-ethylhexyl) phthalate (DEHP), Benzyl Butyl Phthalate (BBP), Dibutyl phthalate (DBP) and Di-isobutyl phthalate (DIBP)) known to be present in the materials employed in excess of the limits laid down, based on information from our suppliers and knowledge of substances used within Pall the manufacturing facility. Pall Medical filters do not employ natural rubber latex, or latex derivatives in their construction. Pall Medical products do not knowingly contain materials of direct animal origin i.e. animal parts, tissues, or body fluids however, to assist our customers in performing a TSE/BSE risk assessment, we are pleased to provide the following information: Certain plastics are known to contain trace levels of additive (e.g. calcium stearate) which are manufactured from tallow. Pall Medical products may utilize components in the fluid pathway which are fabricated from plastic resins containing tallow-derived additives at trace levels, but Pall does not test for them. Please be advised that bovine tallow-derived additives are not considered specified TSE/BSE risk materials according to the current revision of the U.S. Code of Federal Regulations, Title 21 of part 189.5, which defines specified risk material for human food and Regulation (EU) 722/2012 concerning medical devices manufactured using tissues of animal origin, in Article 4, specifically excludes tallow derivatives provided they have been processed under conditions at least as rigorous as those stated in Section 3 of Annex 1 as shown below: • Trans-esterification or hydrolysis at not less than 200 °C for not less than 20 minutes under pressure (glycerol, fatty acids and fatty acid esters production), • Saponification with NaOH 12 M (glycerol and soap production) • Batch process: at not less than 95 °C for not less than 3 hours, • Continuous process: at not less than 140 °C, under pressure for not less than 8 minutes or equivalent, • Distillation at 200 °C. The plastics raw materials we purchase have been processed with one of these steps. Pall continuously works to assure the safety of our products with respect to potential BSE/TSE transmission by working through our supply chain to obtain information regarding the possible use of animal-based material and to confirm specific sourcing and processing details where applicable ______________________________________________________________________________________