Identity
- Trade Name
- Fenwal AMICUS Apheresis Kit - Single Needle FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path. FDA UDI
- Model / Reference
- 4R2357 FDA UDI
- Description
- For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path. FDA UDI
Identifiers
- Catalog Number
- 4R2357 FDA UDI
- Primary DI / UDI-DI
- 04086000101349 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
Fenwal AMICUS Apheresis Kit - Single Needle by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Accessory Platelet Storage Sets — Terumo BCT, Inc.. · Class II
Cleared under the same submission
BK040059 also covers:
BK050038 also covers:
BK150242 also covers:
BK160112 also covers:
- AMICUS Apheresis Kit – Double Needle with Platelet Additive Solution Connector — Fresenius Kabi
- AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector — Fresenius Kabi
- Fenwal AMICUS Apheresis Kit - Double Needle — Fresenius Kabi
- Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed — Fresenius Kabi
- Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed — Fresenius Kabi
- Fenwal AMICUS Apheresis Kit- SingleNeedle w/Platelet Additive Solution Connector — Fresenius Kabi
- Fenwal AMICUS Apheresis Kit-Double Needle w/Platelet Additive Solution Connector — Fresenius Kabi
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 4db0ca5a-0f5d-41bd-b356-f04f5c1e35ec 36 fields · synced Jun 8, 2026