GOJJI BLOOD KETONE TEST STRIP

GUDID 00850001462334

GOJJI, INC.

Glucose/ketone monitoring system IVD, home-use
Primary Device ID00850001462334
NIH Device Record Key8e288122-ff43-4b27-860b-334862be0a6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGOJJI BLOOD KETONE TEST STRIP
Version Model Numberv1
Company DUNS006572586
Company NameGOJJI, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001462334 [Primary]
GS108500014623346 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JINNitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-16
Device Publish Date2020-04-08

Devices Manufactured by GOJJI, INC.

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
00850001462105 - GOJJI LANCING DEVICE WITH CLEAR CAP2020-04-16

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