Prodigy No Coding Blood Glucose Test Strips 075300

GUDID 00384840753006

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

PRODIGY DIABETES CARE, LLC

Glucose IVD, kit, electrometry
Primary Device ID00384840753006
NIH Device Record Keyfda7a56d-0a63-4f28-ab68-bd87093a619c
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdigy No Coding Blood Glucose Test Strips
Version Model Number075300
Catalog Number075300
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
GS100384840753006 [Primary]
GS100384841753005 [Unit of Use]
GS100384843753003 [Package]
Package: Corrugated Carton [20 Units]
In Commercial Distribution
GS100384844753002 [Package]
Contains: 00384843753003
Package: Corrugated 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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