Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-241: ISO 1135-4 Fourth edition 2010-04-15, Transfusion equipment for medical use - Part 4: Transfusion sets for single use. (General Plastic Surgery/General Hospital)
Date of Standard: 2010. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| All blood transfusion sets & accessories |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5440 |
Set, Blood Transfusion |
Class 2 |
BRZ |
| |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on : July 11, 2008 |
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| FDA Technical Contact: |
| Keith Marin |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2567 |
| Silver Spring MD 20993 |
| 301/796-2462 |
| Email: keith.marin@fda.hhs.gov |
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