Identity
- Trade Name
- Kit SST-R 15 shelves 4x3 FDA UDI
- Generic Name
- Blood refrigerator/freezer FDA UDI
- Device Name
- Kit SST-R for the retrofitting of 15 shelves refrigerator 4 by 3 unit slots per shelves FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- Kit SST-R for the retrofitting of 15 shelves refrigerator 4 by 3 unit slots per shelves FDA UDI
Identifiers
- Primary DI / UDI-DI
- B765PRD7130200 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Blood refrigerator/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: Blood refrigerator/freezer
Kit SST-R 15 shelves 4x3 by Biolog-Id — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood refrigerator/freezer.
- K2 Scientific, LLC — K2 Scientific, LLC · Class II
- COREPOINT — HORIZON SCIENTIFIC, INC · Class II
- B Medical Systems — B Medical Systems SARL · Class II
- K2 Scientific, LLC — K2 Scientific, LLC · Class II
- COREPOINT — HORIZON SCIENTIFIC, INC · Class II
- i.Series® — HELMER Inc. · Class II
- COREPOINT — HORIZON SCIENTIFIC, INC · Class II
- COREPOINT — HORIZON SCIENTIFIC, INC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biolog-Id
Sources (1)
- FDA UDI 14d422e2-feac-47dd-b10d-02f9941f9fd3 33 fields · synced Jun 8, 2026