ketodoc Blood Glucose Plus B-Ketone Monitoring System

Primary DI
00717931142227
Brand
ketodoc Blood Glucose Plus B-Ketone Monitoring System
Company
Rediston Limited
Model
TD-4141
Device description
Lancing device*1Lancet*20pcsBlood glucose test strip*10pcsKetone test strip*10pcs
Published
2025-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00717931142227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00717931142227007179311422277179311422270717931142227

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte monitoring system IVD, home-useA collection of devices including a portable, electrically-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 together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended 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.

Regulatory Flags#

DUNS number
663519773
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00717931142241ketodoc Blood Glucose Test Strips (40PCS/BOX)TD-41412025-10-09
00703674534504ketodoc Blood Glucose Test Strips (40PCS/BOX)TD-41412023-03-17
06297001583562ThermobioFDIR-V222025-10-23
00717931142234ketodoc B-Ketone Test Strips (40PCS/BOX)TD-41412025-10-09
00703674534436ketodoc Blood Glucose Plus B-Ketone Monitoring SystemTD-41412023-03-17
00703674534498ketodoc B-Ketone Test Strips (40PCS/BOX)TD-41412023-03-17

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