Identity
- Trade Name
- Amicus MNC Apheresis Kit - Double Needle FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- For Mononuclear Cell (MNC) Collection. For use with the AMICUS separator. Sterile Fluid Path. FDA UDI
- Model / Reference
- X6R2326 FDA UDI
- Description
- For Mononuclear Cell (MNC) Collection. For use with the AMICUS separator. Sterile Fluid Path. FDA UDI
Identifiers
- Catalog Number
- X6R2326 FDA UDI
- Primary DI / UDI-DI
- 04086000100144 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
Amicus MNC Apheresis Kit - Double Needle by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 c2acaef4-7581-4891-8e04-a586154d485d 36 fields · synced Jun 6, 2026