Identity
- Trade Name
- B Medical Systems FDA UDI
- Generic Name
- Rapid-contact laboratory freezer FDA UDI
- Device Name
- Plasma contact shock freezer (remote cooling unit) FDA UDI
- Model / Reference
- CSF61S FDA UDI
- Description
- Plasma contact shock freezer (remote cooling unit) FDA UDI
Identifiers
- Catalog Number
- 991.8936.** FDA UDI
- Primary DI / UDI-DI
- 05450104548031 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Rapid-contact laboratory freezer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9700 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rapid-contact laboratory freezer
B Medical Systems by B Medical Systems SARL — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- B Medical Systems — B Medical Systems SARL · Class II
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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
- B Medical Systems SARL
Sources (1)
- FDA UDI 483b0a70-6457-450a-8ddb-f3305b80233f 35 fields · synced May 30, 2026