Horizon Series™

FDA UDI

Class II (US FDA UDI)

by HELMER Inc.

Identity

Trade Name: Horizon Series™ FDA UDI
Generic Name: Blood refrigerator FDA UDI
Device Name: Pharmacy/Laboratory Refrigerator - Pass-Thru, 58 cu ft FDA UDI
Model / Reference: HPR456 FDA UDI
Description: Pharmacy/Laboratory Refrigerator - Pass-Thru, 58 cu ft FDA UDI

Identifiers

Primary DI / UDI-DI: 00816394020476 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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

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Manufacturer

Manufacturer: HELMER Inc.

Sources (1)

FDA UDI 1e2c9aaa-7ff8-412d-8528-ff945b197f53 34 fields · synced Jun 8, 2026