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Blood Component Filter Set with Vented Spike and Luer Adapter
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- Blood Component Filter Set with Vented Spike and Luer Adapter FDA UDI
- Generic Name
- Blood transfusion set, non-exchange FDA UDI
- Device Name
- For Administration of Blood and Blood Components During a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) Therapeutic Apheresis Procedure. For use with the AMICUS separator. Sterile Fluid Path. FDA UDI
- Model / Reference
- X6C2170 FDA UDI
- Description
- For Administration of Blood and Blood Components During a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) Therapeutic Apheresis Procedure. For use with the AMICUS separator. Sterile Fluid Path. FDA UDI
Identifiers
- Catalog Number
- X6C2170 FDA UDI
- Primary DI / UDI-DI
- 04052682031717 FDA UDI
- FDA Product Code
- LKN FDA UDI
- GMDN Term
- Blood transfusion set, non-exchange FDA UDI
Classification
- Device Class
- U 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 transfusion set, non-exchange
Blood Component Filter Set with Vented Spike and Luer Adapter by Fresenius Kabi — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood transfusion set, non-exchange.
- Blood Administration Set — Merit Pharmaceutical · Class II
- Walrus — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · Class II
- Blood Administration Set — B. BRAUN MEDICAL INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- CLEARLINK — BAXTER INTERNATIONAL INC. · Class II
- CODAN — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · Class II
Cleared under the same submission
K111702 also covers:
K180615 also covers:
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 U | Pending data |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 5bd37038-ad79-4921-b8b2-5afd80277c46 36 fields · synced Jun 8, 2026