FDA.reportPublic FDA data

Equate Blood Glucose Test Strips

Primary DI
00681131304863
Brand
Equate Blood Glucose Test Strips
Company
UNISTRIP TECHNOLOGIES, LLC
Model
038600
Catalog number
038600
Device description
Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00681131304863PackageGS124Not in Commercial Distribution
10681131104866PackageGS124In Commercial Distribution
30681131104860PackageGS11In Commercial Distribution
00681131104869PrimaryGS10
49035-0386-00SecondaryNDC/NHRIC0
00068113004862Unit of UseGS10
90681131104862Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681131304863006811313048636811313048630681131304863
1068113110486610681131104866
3068113110486030681131104860
00681131104869006811311048696811311048690681131104869
00068113004862000681130048620681130048620068113004862
9068113110486290681131104862

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043251054
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00389167248501UniStrip1 Generic Blood Glucose Test Strip0248500248502016-09-24
00681131104869Equate Blood Glucose Test Strips0386000386002016-09-24
00389167362108UniStrip Control Solution Low0362100362102016-09-23
00389167348508UniStrip1 Generic Blood Glucose Test Strip0248500248502016-09-24
00389167262101UniStrip Control Solution Low0362100362102016-09-23

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Primary DI, Brand, Company table
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30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
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10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
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