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Fenwal PlasmaLink Transfer-Pack Container with Luer Adapter and No Outlet Ports
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Fenwal PlasmaLink Transfer-Pack Container with Luer Adapter and No Outlet Ports FDA UDI
- Generic Name
- Blood/tissue storage/culture container FDA UDI
- Device Name
- For processing and/or storage of blood or blood components. Sterile Fluid Path. FDA UDI
- Model / Reference
- 4R2088P FDA UDI
- Description
- For processing and/or storage of blood or blood components. Sterile Fluid Path. FDA UDI
Identifiers
- Catalog Number
- 4R2088P FDA UDI
- Primary DI / UDI-DI
- 14086000101414 FDA UDI
- FDA Product Code
- KSR FDA UDI
- GMDN Term
- Blood/tissue storage/culture container FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood/tissue storage/culture container
Fenwal PlasmaLink Transfer-Pack Container with Luer Adapter and No Outlet Ports by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 0ef14dc0-19cc-4c38-9acc-110017e8f537 35 fields · synced Jun 8, 2026