PRODIGY PRO No Coding Blood Glucose Test Strips 051700

GUDID 30384840517005

PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct) Individually Wrapped Foil Packs for Professional Use

PRODIGY DIABETES CARE, LLC

Glucose monitoring system IVD, point-of-care
Primary Device ID30384840517005
NIH Device Record Key775aadac-ceff-4111-bb88-67b793ef1864
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRODIGY PRO No Coding Blood Glucose Test Strips
Version Model Number051700
Catalog Number051700
Company DUNS832875905
Company NamePRODIGY DIABETES CARE, LLC
Device Count50
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com
Phone1 (800) 243-2636
Emailinfo@prodigymeter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100384840517004 [Primary]
NDC/NHRIC08484-0517-00 [Secondary]
GS110384840517001 [Unit of Use]
GS130384840517005 [Package]
Contains: 00384840517004
Package: Inner Case [15 Units]
In Commercial Distribution
GS140384840517002 [Package]
Package: Master Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-30
Device Publish Date2020-09-22

Devices Manufactured by PRODIGY DIABETES CARE, LLC

00384843104003 - Prodigy No Coding Blood Glucose Test Strips2024-07-18 1 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct)
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30384840517005 - PRODIGY PRO No Coding Blood Glucose Test Strips2020-09-30 PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct) Individually Wrapped Foil Packs for Professional Use
00384840517752 - PRODIGY Astro PRO Blood Glucose Monitoring System2020-09-30 PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
00384841732000 - Prodigy No Coding Blood Glucose Test Strips2019-02-18 Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.
00384840810280 - Prodigy Twist Top Lancets2018-09-21 Prodigy Twist Top Lancets 28G (100 ct)
00384840823167 - Prodigy Pressure Activated Safety Lancets2018-09-21 Prodigy Pressure Activated Safety Lancets 26G (100 ct)
30384840823410 - Prodigy Pressure Activated Safety Lancets2018-09-21 Prodigy Pressure Activated Safety Lancets 21G (100 ct)
00384840832251 - Prodigy Adjustable Depth Lancing Device2018-09-21 Prodigy Adjustable Depth Lancing Device

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