Identity
- Trade Name
- Horizon Series™ FDA UDI
- Generic Name
- Blood refrigerator FDA UDI
- Device Name
- Pharmacy Refrigerator, 11 cu ft FDA UDI
- Model / Reference
- HPR111 FDA UDI
- Description
- Pharmacy Refrigerator, 11 cu ft FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816394020414 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
- 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
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
Horizon Series™ by HELMER 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
- HELMER Inc.
Sources (1)
- FDA UDI 4d747a84-22f9-4918-999a-c62d166c6e0d 35 fields · synced Jun 8, 2026