Prodigy No Coding Blood Glucose Test Strips 052825

GUDID 00384844528259

1 Box of Prodigy No Coding Blood Glucose Test Strips (25 ct).

PRODIGY DIABETES CARE, LLC

Glucose IVD, kit, electrometry
Primary Device ID00384844528259
NIH Device Record Keye3d3097b-ba17-4596-8b79-9d76d5d53a24
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdigy No Coding Blood Glucose Test Strips
Version Model Number052825
Catalog Number052825
Company DUNS832875905
Company NamePRODIGY DIABETES CARE, LLC
Device Count25
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
GS100384840528253 [Primary]
GS100384841528252 [Unit of Use]
GS100384843528250 [Package]
Contains: 00384840528253
Package: Corrugated Carton [20 Units]
In Commercial Distribution
GS100384844528259 [Package]
Contains: 00384843528250
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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003848447250091 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
003848445282591 Box of Prodigy No Coding Blood Glucose Test Strips (25 ct).
003848405281091 Vial of Prodigy No Coding Blood Glucose Test Strips (10 ct).
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