Identity
- Trade Name
- Thermo Scientific Sorvall Blood Washing System FDA UDI
- Generic Name
- Cell washer IVD FDA UDI
- Device Name
- Sorvall Cell Washer 2+ ,100/120/240V 60Hz FDA UDI
- Model / Reference
- CW2 Plus FDA UDI
- Description
- Sorvall Cell Washer 2+ ,100/120/240V 60Hz FDA UDI
Identifiers
- Catalog Number
- 80300566, 80300567 FDA UDI
- Primary DI / UDI-DI
- 10816934020772 FDA UDI
- FDA Product Code
- KSN FDA UDI
- GMDN Term
- Cell washer IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9285 FDA UDI
- Commercial Distribution
- Not 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
Thermo Scientific Sorvall Blood Washing System by Key Scientific Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Key Scientific Inc
Sources (1)
- FDA UDI a9057869-6593-4268-ab14-2a2fde03cbc0 36 fields · synced May 30, 2026