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Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter FDA UDI
- Generic Name
- Blood transfer set FDA UDI
- Device Name
- For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path. FDA UDI
- Model / Reference
- 4C2304 FDA UDI
- Description
- For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path. FDA UDI
Identifiers
- Catalog Number
- 4C2304 FDA UDI
- Primary DI / UDI-DI
- M5264C23041 FDA UDI
- FDA Product Code
- GKT FDA UDI
- GMDN Term
- Blood transfer set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 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 transfer set
Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter 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 ef6f0186-371b-4ded-a6a9-1388d38cbb87 36 fields · synced May 30, 2026