Identity
- Trade Name
- Trima Accel® FDA UDI
- Generic Name
- Apheresis system FDA UDI
- Device Name
- Automated Blood Collection System FDA UDI
- Model / Reference
- 81000 FDA UDI
- Description
- Automated Blood Collection System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05020583810006 FDA UDI
- FDA Product Code
- GKT 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Apheresis system
Trima Accel® by Terumo BCT, Inc.. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Apheresis system.
- Aurora Software Version 1.3 Upgrade Kit — Fresenius Kabi · Class II
- Aurora Xi Plasmapheresis System — Fresenius Kabi · Class II
- Aurora Plasmapheresis System — Fresenius Kabi · Class II
- AMICUS Separator Legacy Software — Fresenius Kabi · Class II
- Aurora Xi Plasmapheresis System — Fresenius Kabi · Class II
- Aurora Plasmapheresis System Software Version 2.1 — Fresenius Kabi · Class II
- MCS+ — HAEMONETICS CORPORATION · Class II
- Angel Whole Blood Processing System — NUO THERAPEUTICS, INC. · Class II
Cleared under the same submission
BK150269 also covers:
BK970023 also covers:
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
- Terumo BCT, Inc..
Sources (1)
- FDA UDI a9d9cfcb-bd30-4015-acd2-84e6398970be 36 fields · synced May 30, 2026