Identity
- Trade Name
- AMICUS Separator Life Extension Software FDA UDI
- Generic Name
- Apheresis system FDA UDI
- Device Name
- Software version for AMICUS Separator Life Extension Device FDA UDI
- Model / Reference
- 6.1.122.0 FDA UDI
- Description
- Software version for AMICUS Separator Life Extension Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810020441192 FDA UDI
- FDA Product Code
- GKT FDA UDILKN FDA UDI
- GMDN Term
- Apheresis system 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Apheresis system
AMICUS Separator Life Extension Software by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Apheresis system.
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Cleared under the same submission
BK230824 also covers:
- AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike — Fresenius Kabi
- AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike — Fresenius Kabi
- AMICUS Separator Legacy Software — Fresenius Kabi
- AMICUS Separator Legacy Software — Fresenius Kabi
- AMICUS Separator Life Extension Software — Fresenius Kabi
- Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual — Fresenius Kabi
- Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual — 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 1f517965-62db-41b5-8f76-c3d7494419bb 34 fields · synced May 30, 2026