FDA.reportPublic FDA data

Meijer Essential Blood Glucose Test Strips

Primary DI
20713733070335
Brand
Meijer Essential Blood Glucose Test Strips
Company
MEIJER, INC.
Model
8000-07075
Device description
Test Strips, Meijer, Essential, 50CT, 100CT
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00713733070300PackageGS12Not in Commercial Distribution
00713733070331PackageGS11Not in Commercial Distribution
10713733070307PackageGS112Not in Commercial Distribution
10713733070338PackageGS124Not in Commercial Distribution
20713733070335PrimaryGS10
30713733070325Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00713733070300007137330703007137330703000713733070300
00713733070331007137330703317137330703310713733070331
1071373307030710713733070307
1071373307033810713733070338
2071373307033520713733070335
3071373307032530713733070325

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
006959555
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00719283338334Meijer Hot & Cold Compression Migraine Mask7192833383342024-04-03
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00708820523418Meijer Hot & Cold Therapy Wrap with Clay Based Technology34583982017-08-01
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Primary DI, Brand, Company table
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