AIMSTRIP PLUS LANCETS

GUDID 00695684373115

Lancets (sterile) for use with Blood Glucose Test Strips & meter for testing blood glucose levels

GERMAINE LABORATORIES, INC

Home-use blood glucose spot-check analysis system Home-use blood glucose spot-check analysis 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 Home-use blood glucose spot-check system
Primary Device ID00695684373115
NIH Device Record Key62bdc17c-93cf-4d23-ac64-15ee08b968dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIMSTRIP PLUS LANCETS
Version Model Number37311
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count100
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
GS100695684373112 [Unit of Use]
GS100695684373115 [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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