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ALYX 2RBC LR Kit with Saline Spike
FDA UDIClass II (US FDA UDI)
by Fenwal, Inc.
Identity
- Trade Name
- ALYX 2RBC LR Kit with Saline Spike FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile Fluid Path. FDA UDI
- Model / Reference
- 4R5742 FDA UDI
- Description
- For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile Fluid Path. FDA UDI
Identifiers
- Catalog Number
- 4R5742 FDA UDI
- Primary DI / UDI-DI
- 00811137012992 FDA UDI
- FDA Product Code
- GKT FDA UDI
- GMDN Term
- Apheresis system tubing 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: Apheresis system tubing set
ALYX 2RBC LR Kit with Saline Spike by Fenwal, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Apheresis system tubing set.
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- AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike — Fresenius Kabi · Class II
Cleared under the same submission
BK150236 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 II | Pending data |
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Manufacturer
- Manufacturer
- Fenwal, Inc.
Sources (1)
- FDA UDI 73e8f482-8012-49c1-9652-e6281fe942e4 36 fields · synced Jun 1, 2026