Identity
- Trade Name
- Horizon Series™ FDA UDI
- Generic Name
- Blood refrigerator FDA UDI
- Device Name
- Blood Bank Refrigerator - Undercounter, 5 cu ft FDA UDI
- Model / Reference
- HB105 FDA UDI
- Description
- Blood Bank Refrigerator - Undercounter, 5 cu ft FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816394020100 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
Yes
FDA UDI
Category: Blood refrigerator
Horizon Series™ by HELMER Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood refrigerator.
- BL 100 PRO-ACTIVE E — Philipp Kirsch GmbH · Class IIa
- BLOODBANK — FRI.MED. S.R.L. · Class IIa
- Medical Refrigerator — Jinan Biobase Biotech Co., Ltd. · Class I
- Cardinal Health Blood Bank Refrigerator — KEY SCIENTIFIC INC · Class II
- BL 300 ULTIMATE E — Philipp Kirsch GmbH · Class IIa
- HEMOVAULT by ACCUCOLD — FELIX STORCH, INC. · Class II
- BLOODBANK — FRI.MED. S.R.L. · Class IIa
- Follett — Follett Corporation · 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
- HELMER Inc.
Sources (1)
- FDA UDI de89767b-9ac0-4349-ab81-c2c5782c8dca 34 fields · synced Jun 1, 2026