Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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1-81
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Standard | |
CGA V-5:2008 (Reaffirmed 2013) Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) |
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Scope/AbstractProvides dimensions and other data to produce or use medical designed fittings for various gas connections used in hospital or patient care applications. The fittings are gas specific and noninterchangeable. This will avoid cross-connection of medical gases. |
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Extent of Recognition
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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. |
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Transition Period
FDA recognition of CGA V-5:2008 (Reaffirmed 2013) [Rec# 1-81] will be superseded by recognition of CGA V-5:2019 [Rec# 1-167]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-81] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 1-81] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§868.2700 |
Regulator, Pressure, Gas Cylinder
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Class 1
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CAN
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§868.5160 |
Gas-Machine, Anesthesia
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Class 2
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BSZ
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§868.5925 |
Ventilator, Emergency, Powered (Resuscitator)
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Class 2
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BTL
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |