GOJJI Plus TestNGo MULTIFUNCTION (GLUC-KETONE) METER

GUDID 00850001462136

GOJJI, INC.

Multiple clinical chemistry analyte monitoring system IVD, home-use
Primary Device ID00850001462136
NIH Device Record Key4b8f6c39-6491-41c7-9a37-3cf6c832bf72
Commercial Distribution StatusIn Commercial Distribution
Brand NameGOJJI Plus TestNGo MULTIFUNCTION (GLUC-KETONE) METER
Version Model NumberV1
Company DUNS006572586
Company NameGOJJI, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001462136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-09
Device Publish Date2026-02-01

Devices Manufactured by GOJJI, INC.

00850001462136 - GOJJI Plus TestNGo MULTIFUNCTION (GLUC-KETONE) METER2026-02-09
00850001462136 - GOJJI Plus TestNGo MULTIFUNCTION (GLUC-KETONE) METER2026-02-09
00850001002011 - GOJJI BLOOD PRESSURE WELCOME KIT2020-12-31
00850001462112 - GOJJI MULTIFUNCTION (GLUC-KETONE) METER2020-04-28
00850001462129 - GOJJI MULTIFUNCTION (GLUC-KETONE) METER2020-04-28
00850001462402 - GOJJI GLUCOSE CONTROL SOLN-NORMAL2020-04-28
00850001462419 - GOJJI KETONE CONTROL SOLUTION-L12020-04-28
00850001462006 - GOJJI MULTIFUNCTION (GLUC-KETONE) KT2020-04-16
00850001462037 - GOJJI MULTIFUNCTION (GLUC-KETONE) KT2020-04-16

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