FDA.reportPublic FDA data

CareLiving Blood Glucose Test Strips 50ct

Primary DI
00383568100857
Brand
CareLiving Blood Glucose Test Strips 50ct
Company
Care Living Diagnostics Inc.
Model
CL-50
Catalog number
83568-1008-57
Device description
Blood Glucose Test Strips,2 bottles of 25 strips in one 50 strip box, for use with blood glucose monitoring system
Published
2023-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00383568100857PrimaryGS10
10383568100854Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00383568100857003835681008573835681008570383568100857
1038356810085410383568100854

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. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).

Regulatory Flags#

DUNS number
125354643
Device count
50
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10383568400244EasyLife Mini Safety Pen Needles 4MM 31G 100pcsEL420483568-4002-472025-09-18

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