Prodigy Combo Pre-Pack

Primary DI
00384840751002
Brand
Prodigy Combo Pre-Pack
Company
Prodigy Diabetes Care, LLC
Model
075100
Catalog number
075100
Device description
Prodigy Combo Pre-Pack20 x Item # 073200; 5 x Item # 07120
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00384840751002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384840751002003848407510023848407510020384840751002

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, reusableA hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832875905
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

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Primary DI, Brand, Model table
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