Identity
- Trade Name
- COBE® 2991 FDA UDI
- Generic Name
- Cell washer IVD FDA UDI
- Device Name
- Blood Cell Processor FDA UDI
- Model / Reference
- 91000 FDA UDI
- Description
- Blood Cell Processor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05020583910003 FDA UDI
- 510(k) Number
- K893962 FDA UDI
- FDA Product Code
- GKT FDA UDI
- GMDN Term
- Cell washer IVD 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: Cell washer IVD
Cobe® 2991 by Terumo BCT, Inc.. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cell washer IVD.
- UltraCW® — HELMER Inc. · Class II
- UltraCW®II — HELMER Inc. · Class II
Cleared under the same submission
K893962 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 |
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Manufacturer
- Manufacturer
- Terumo BCT, Inc..
Sources (1)
- FDA UDI 4220e831-57ea-4c64-8ecc-18f602e6a277 35 fields · synced Jun 1, 2026