Identity
- Trade Name
- Autonomous Portable Refrigeration Unit FDA UDI
- Generic Name
- Blood refrigerator FDA UDI
- Device Name
- Portable blood refrigerator, battery powered, 6 liter FDA UDI
- Model / Reference
- 6L-2 FDA UDI
- Description
- Portable blood refrigerator, battery powered, 6 liter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006680909 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Blood refrigerator 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
No
FDA UDI
Category: Blood refrigerator
Autonomous Portable Refrigeration Unit by Delta Development Team Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Horizon Series™ — HELMER 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 |
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Manufacturer
- Manufacturer
- Delta Development Team Inc
Sources (1)
- FDA UDI b28d75f1-b037-4884-83be-189c7fa7c1c7 34 fields · synced Jun 8, 2026