IDEAL LIFE Control Solution Level II

FDA UDI

Class II (US FDA UDI)

by Ideal Life, Inc.

Identity

Trade Name: IDEAL LIFE Control Solution Level II FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions contains a known amount of glucose that reacts with the test strips. FDA UDI
Model / Reference: GCS0104 FDA UDI
Description: For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions contains a known amount of glucose that reacts with the test strips. FDA UDI

Identifiers

Primary DI / UDI-DI: 00804084000150 FDA UDI
FDA Product Code: NBW FDA UDI
JJX FDA UDI
CGA FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

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

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Circumference — 56 Millimeter FDA UDI
Height — 56 Millimeter FDA UDI
Weight — 5 Gram FDA UDI

Category: Glucose monitoring system IVD, home-use

IDEAL LIFE Control Solution Level II by Ideal Life, 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: Ideal Life, Inc.

Sources (1)

FDA UDI c57046e2-e176-406b-9c7a-2bb3277d6ce3 36 fields · synced Jun 1, 2026