GOJJI BLOOD PRESSURE WELCOME KIT

GUDID 00850001002011

GOJJI, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00850001002011
NIH Device Record Key43484000-b92c-46c0-8a35-6a0d8e492b44
Commercial Distribution StatusIn Commercial Distribution
Brand NameGOJJI BLOOD PRESSURE WELCOME KIT
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
GS100850001002011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-31
Device Publish Date2020-12-23

Devices Manufactured by GOJJI, INC.

00850001002011 - GOJJI BLOOD PRESSURE WELCOME KIT2020-12-31
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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