Ge

FDA UDI

Class I (US FDA UDI)

by Bionime Corporation

Identity

Trade Name: GE FDA UDI
Generic Name: Glucose IVD, control FDA UDI
Device Name: GE333 control solution (High level) FDA UDI
Model / Reference: GE333 FDA UDI
Description: GE333 control solution (High level) FDA UDI

Identifiers

Primary DI / UDI-DI: 00883489001818 FDA UDI
FDA Product Code: JJX FDA UDI
NBW FDA UDI
GMDN Term: Glucose IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1345 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

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose IVD, control

Ge by Bionime Corporation — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Bionime Corporation

Sources (1)

FDA UDI faa99754-6c3c-46d6-b2d4-0857582b23ff 34 fields · synced Jun 8, 2026