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Amicus Double Needle Advanced Kit with Platelet Additive Solution Connector
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Amicus Double Needle Advanced Kit with Platelet Additive Solution Connector FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. FDA UDI
- Model / Reference
- 4R2352 FDA UDI
- Description
- For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. FDA UDI
Identifiers
- Catalog Number
- 4R2352 FDA UDI
- Primary DI / UDI-DI
- 00810020440713 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 Double Needle Advanced Kit with Platelet Additive Solution Connector by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID
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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 e72b5d62-7a3a-4b42-8809-fd26d47d6be5 35 fields · synced May 31, 2026