FDA.report

TopCare Premium Blood Glucose Test Strips

Primary DI
10036800367453
Brand
TopCare Premium Blood Glucose Test Strips
Company
TOPCO ASSOCIATES, LLC
Model
8000-07158
Device description
Test Strips, TopCare, Premium, 50CT, 100CT
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
true

Related Records

Product Codes

CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00036800367449PackageGS11In Commercial Distribution
00036800367456PackageGS12In Commercial Distribution
10036800367446PackageGS124In Commercial Distribution
10036800367453PackageGS112In Commercial Distribution
20036800367443PrimaryGS10
30036800422156Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00036800367449000368003674490368003674490036800367449
00036800367456000368003674560368003674560036800367456
1003680036744610036800367446
1003680036745310036800367453
2003680036744320036800367443
3003680042215630036800422156

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
072943876
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

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10036800216607TopCare health0368002166002019-07-31
10036800232690TOPCARE87-691-00187-691-0012016-09-12
10036800232706TOPCARE87-605-00187-605-0012016-09-12
10036800232713TOPCARE87-736-00187-736-0012016-09-13
10036800250762TopCare Insulin Syringe0329122016-09-24
10036800250779TopCare Insulin Syringe0529122016-09-24
10036800250786TopCare Insulin Syringe1029122016-10-04
10036800250793TopCare Insulin Syringe0330082016-09-24
10036800250809TopCare Insulin Syringe0530082016-09-24
10036800250816TopCare Insulin Syringe1030082016-09-24
10036800250823TopCare Insulin Syringe0331082016-09-24
10036800250830TopCare Insulin Syringe0531082016-09-24

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