Horizon Series™

FDA UDI

Class II (US FDA UDI)

by HELMER Inc.

Identity

Trade Name: Horizon Series™ FDA UDI
Generic Name: Blood plasma freezer FDA UDI
Device Name: -20°C / -30°C Laboratory Freezer - Undercounter, 4 cu ft FDA UDI
Model / Reference: HLF104-ADA FDA UDI
Description: -20°C / -30°C Laboratory Freezer - Undercounter, 4 cu ft FDA UDI

Identifiers

Primary DI / UDI-DI: 00816394020605 FDA UDI
FDA Product Code: KSE FDA UDI
GMDN Term: Blood plasma 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

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 plasma freezer

Horizon Series™ by HELMER Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 ff6c73b4-8374-4986-a56a-16e6af4bba9e 34 fields · synced May 30, 2026