Prodigy No Coding Blood Glucose Test Strips 072500

GUDID 00384844725009

1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).

PRODIGY DIABETES CARE, LLC

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Primary Device ID00384844725009
NIH Device Record Key0b69e429-36c2-4839-bacb-69ec6cec10af
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdigy No Coding Blood Glucose Test Strips
Version Model Number072500
Catalog Number072500
Company DUNS832875905
Company NamePRODIGY DIABETES CARE, LLC
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.

Device Identifiers

Device Issuing AgencyDevice ID
GS100384840725003 [Primary]
GS100384841725002 [Unit of Use]
GS100384843725000 [Package]
Contains: 00384840725003
Package: Corrugated Carton [20 Units]
In Commercial Distribution
GS100384844725009 [Package]
Contains: 00384843725000
Package: Corrogated Carton [10 Units]
In Commercial Distribution

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21

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