i.Series®

FDA UDI

Class II (US FDA UDI)

by HELMER Inc.

Identity

Trade Name: i.Series® FDA UDI
Generic Name: Blood refrigerator/freezer FDA UDI
Device Name: Blood Bank Compartmental Access Refrigerator 80 Bin FDA UDI
Model / Reference: iBX080-GX FDA UDI
Description: Blood Bank Compartmental Access Refrigerator 80 Bin FDA UDI

Identifiers

Primary DI / UDI-DI: 00816394021770 FDA UDI
FDA Product Code: KSE FDA UDI
GMDN Term: Blood refrigerator/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

Yes

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 Blood refrigerator/freezer

i.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 f58cab28-f4ef-4feb-9079-f2560bf3cb2c 33 fields · synced May 30, 2026