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New Search Back To Search Results Part B: Supplementary Information Sheet (SIS) 049 Date of Entry06/07/2018 Standard ISO7199 Third edition 2016-11-15Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). U.S. Identical Adoption ANSI AAMI ISO7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). Scope/Abstract This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. This document also applies to external equipment unique to the use of the oxygenator. Extent of Recognition Complete standard Rationale for Recognition This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. Public Law, CFR Citation(s) and Procode(s)* Regulation Number Device Name Device Class Product Code §870.4350 Oxygenator, Cardiopulmonary Bypass Relevant FDA Guidance and/or Supportive Publications* Guidance for Cardiopulmonary Bypass Oxygenator 510(k) Submissions; Final Guidance for Industry and FDA Staff, Issued November 2000. FDA Technical Contacts Catherine Wentz FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/ 301-796-6339 catherine.wentz@fda.hhs.gov Qijin Lu FDA/OC/CDRH/OSEL/DAM/ 301-796-2528 qijin.lu@fda.hhs.gov Standards Development Organization International Organization for Standardization FDA Specialty Task Group (STG) Cardiovascular *These are provided as examples and others may be applicable. PS3 Game Name: Catherine PS3 ISO Region: USA Working on: 3.55 Kmeaw Mirrors Available: FileOM Catherine (USA) (NTSC) PS3 ISO Download Links Catherine.PS3-iMARS.part01.rar – 999.0 MB Catherine.PS3-iMARS.part02.rar – 999.0 MB Catherine.PS3-iMARS.part03.rar – 999.0 MB Catherine.PS3-iMARS.part04.rar – 999.0 MB Catherine.PS3-iMARS.part05.rar – 999.0 MB Catherine.PS3-iMARS.part06.rar – 999.0 MB Catherine.PS3-iMARS.part07.rar – 999.0 MB Catherine Isobel Catherine.PS3-iMARS.part08.rar – 999.0 MB Catherine.PS3-iMARS.part09.rar – 999.0 MB Catherine.PS3-iMARS.part10.rar – 816.5 MB Please leave a comment when you find a broken link! Leave a comment to discuss about the PS3 games Katharine Isabelle See No Evil 2 too!