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GenUltimate!

FDA UDI

Class II (US FDA UDI)

by Pharma Tech Solutions, Inc.

Identity

Trade Name
GenUltimate! FDA UDI
Generic Name
Home-use/point-of-care glucose rapid test/blood pressure system analyser FDA UDI
Device Name
Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters. FDA UDI
Model / Reference
100-50 FDA UDI
Description
Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters. FDA UDI

Identifiers

Catalog Number
100-50 FDA UDI
Primary DI / UDI-DI
00868906000100 FDA UDI
FDA Product Code
CGA FDA UDI
GMDN Term
Home-use/point-of-care glucose rapid test/blood pressure system analyser FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Home-use/point-of-care glucose rapid test/blood pressure system analyser

GenUltimate! by Pharma Tech Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home-use/point-of-care glucose rapid test/blood pressure system analyser.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pharma Tech Solutions, Inc.

Sources (1)

  • FDA UDI 9368f0cd-a038-444b-9305-a96944a294d6 35 fields · synced Jun 8, 2026