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Gojji Multifunction (gluc-Ketone) Meter

FDA UDI

Class II (US FDA UDI)

by Gojji, Inc.

Identity

Trade Name
GOJJI MULTIFUNCTION (GLUC-KETONE) METER FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Model / Reference
V1 FDA UDI

Identifiers

Primary DI / UDI-DI
00850001462112 FDA UDI
510(k) Number
K173505 FDA UDI
FDA Product Code
NBW FDA UDI
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, home-use 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry analyte monitoring system IVD, home-use

Gojji Multifunction (gluc-Ketone) Meter by Gojji, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyte monitoring system IVD, home-use.

Cleared under the same submission

K173505 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gojji, Inc.

Sources (1)

  • FDA UDI 92ddadc2-bf5f-48b7-bf78-1db8a64f63a6 33 fields · synced May 31, 2026