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Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the Amicus Separator. FDA UDI
- Model / Reference
- 4R2361 FDA UDI
- Description
- For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the Amicus Separator. FDA UDI
Identifiers
- Catalog Number
- 4R2361 FDA UDI
- Primary DI / UDI-DI
- 00810020441642 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 Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Apheresis system tubing set.
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- JMS SYSLOC APHERESIS NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
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- Accessory Platelet Storage Sets — Terumo BCT, Inc.. · Class II
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 Separator Life Extension Software — 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 |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI ab4b78f0-8843-4cad-8a7c-4efc22213457 36 fields · synced Jun 1, 2026