AIMSTRIP PLUS BLOOD GLUCOSE METER, BOX KIT

GUDID 00695684373214

A blood glucose meter for use with AimStrip® Plus Blood Glucose Test Strips for testing blood glucose levels.

GERMAINE LABORATORIES, INC

Home-use/point-of-care blood glucose monitoring system IVD Home-use/point-of-care blood glucose monitoring system IVD Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system
Primary Device ID00695684373214
NIH Device Record Keyb5efc267-34b7-48d7-8d95-f6c4aa041e90
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMSTRIP PLUS BLOOD GLUCOSE METER, BOX KIT
Version Model Number37321
Company DUNS176458115
Company NameGERMAINE LABORATORIES, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100695684373214 [Primary]

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-27

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