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AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. FDA UDI
- Model / Reference
- 4R2358 FDA UDI
- Description
- For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. FDA UDI
Identifiers
- Catalog Number
- 4R2358 FDA UDI
- Primary DI / UDI-DI
- 00810020440270 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 Single Needle with PAS Spike by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Apheresis system tubing set.
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- HAEMONETICS MCS+ (LN8150) RBC APHERESIS — HAEMONETICS CORPORATION · Class II
- Haemonetics® NexSys PCS® System — HAEMONETICS CORPORATION · Class II
- JMS SYSLOC APHERESIS NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
- JMS WINGEATER APHERESIS NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
- 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 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 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 |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 0a50cea9-00d8-4e11-be46-eafc28283918 36 fields · synced Jun 8, 2026