Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-79: ISO 26825 First edition 2008-08-15, Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance. (Anesthesias)
Date of Standard: 2008. |
| 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: |
| Syringes (GHDB), Dosing pumps (i.e Propofol), Anesthesia conduction kits (both spinal/epidural, and regional block) |
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| Processes Affected: |
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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 |
| §868.5140 |
Anesthesia Conduction Kit |
Class 2 |
CAZ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5725 |
Pump, Infusion |
Class 2 |
FRN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5860 |
Syringe, Piston |
Class 2 |
FMF |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Nayan Patel |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2550 |
| Silver Spring MD 20993 |
| 301/796-4110 |
| Email: nayan.patel@fda.hhs.gov |
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