FDA.reportPublic FDA data

Prodigy No Coding Blood Glucose Test Strips

Primary DI
00384840732001
Brand
Prodigy No Coding Blood Glucose Test Strips
Company
Prodigy Diabetes Care, LLC
Model
073200
Catalog number
073200
Device description
1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
Published
2016-09-21
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
00384843732008PackageGS120In Commercial Distribution
00384844732007PackageGS110In Commercial Distribution
00384840732001PrimaryGS10
00384841732000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384843732008003848437320083848437320080384843732008
00384844732007003848447320073848447320070384844732007
00384840732001003848407320013848407320010384840732001
00384841732000003848417320003848417320000384841732000

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.

Regulatory Flags#

DUNS number
832875905
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384840104006Prodigy No Coding Blood Glucose Test Strips0104000104002024-07-10
00384840518902Prodigy AutoCode Blood Glucose Monitoring System0518900518902016-09-22
00384840519008Prodigy Voice Blood Glucose Monitoring System0519000519002016-09-22
00384840528253Prodigy No Coding Blood Glucose Test Strips0528250528252016-09-21
00384840719507Prodigy Voice Blood Glucose Monitoring System0719500719502016-09-22
00384840725003Prodigy No Coding Blood Glucose Test Strips0725000725002016-09-21
00384840761506Prodigy iConnect Blood Glucose Monitoring System0761500761502016-09-23
00384840528000Prodigy No Coding Blood Glucose Test Strips0528000528002016-09-21
00384840528109Prodigy No Coding Blood Glucose Test Strips0528100528102016-09-21
00384840751002Prodigy Combo Pre-Pack0751000751002016-09-21
00384840751507Prodigy Value Pack0751500751502016-09-21
00384840753006Prodigy No Coding Blood Glucose Test Strips0753000753002016-09-21
00384840517004PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips0517000517002020-09-22
00384840105003Prodigy No Coding Blood Glucose Test Strips0105000105002024-07-11
00384843104003Prodigy No Coding Blood Glucose Test Strips0104000104002024-07-10
00384840750500Prodigy No Coding Blood Glucose Test Strips750500750502019-01-16
00384840518858Prodigy AutoCode Blood Glucose Monitoring System0518850518852016-09-21
00384840701205Prodigy AutoCode Blood Glucose Monitoring System0701200701202016-09-21
00384840708020Prodigy Pocket Blood Glucose Monitoring System0708020708022016-09-21
00384840743007Prodigy AutoCode Blood Glucose Monitoring System0743000743002016-11-07

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Primary DI, Brand, Company table
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08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
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