Equate Blood Glucose Test Strips 038600

GUDID 00681131304863

Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.

UNISTRIP TECHNOLOGIES, LLC

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Primary Device ID00681131304863
NIH Device Record Key215d2f11-b06a-4575-bb52-706f97cd61a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquate Blood Glucose Test Strips
Version Model Number038600
Catalog Number038600
Company DUNS043251054
Company NameUNISTRIP TECHNOLOGIES, LLC
Device Count50
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.

Device Identifiers

Device Issuing AgencyDevice ID
GS100068113004862 [Unit of Use]
GS100681131104869 [Primary]
GS100681131304863 [Package]
Contains: 00681131104869
Package: Corrugated Carton [24 Units]
Discontinued: 2020-02-05
Not in Commercial Distribution
GS110681131104866 [Package]
Contains: 00681131104869
Package: Corrugated Carton [24 Units]
In Commercial Distribution
GS130681131104860 [Package]
Contains: 00681131104869
Package: Vial [1 Units]
In Commercial Distribution
NDC/NHRIC49035-0386-00 [Secondary]
GS190681131104862 [Unit of Use]

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 Number3
Public Version Date2020-02-06
Device Publish Date2016-09-24

Devices Manufactured by UNISTRIP TECHNOLOGIES, LLC

00681131304863 - Equate Blood Glucose Test Strips2020-02-06Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
00681131304863 - Equate Blood Glucose Test Strips2020-02-06 Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before Ap
00389167348508 - UniStrip1 Generic Blood Glucose Test Strip2018-03-29 UniStrip1 Generic Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchase
00389167262101 - UniStrip Control Solution Low2018-03-29 UniStrip Control Solution Low 4mL

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