Identity
- Trade Name
- Kit SST-R HD 60 cm FDA UDI
- Generic Name
- Blood refrigerator/incubator FDA UDI
- Device Name
- Kit SST-R HD for the retrofitting shelves of refrigerator 60cm FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- Kit SST-R HD for the retrofitting shelves of refrigerator 60cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B765PRD7170205 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Blood refrigerator/incubator 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: Blood refrigerator/incubator
Kit SST-R HD 60 cm by Biolog-Id — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood refrigerator/incubator.
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- Kit SST-R HD 60cm ColdRoom — BIOLOG-ID · Class II
- Kit SST-A 10 for PF96 — BIOLOG-ID · Class II
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
- Biolog-Id
Sources (1)
- FDA UDI 836acb9e-6731-484e-b788-020b2218e4bc 33 fields · synced Jun 8, 2026