Prodigy No Coding Blood Glucose Test Strips 75050

GUDID 00384841732000

Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.

PRODIGY DIABETES CARE, LLC

Glucose monitoring system IVD, home-use
Primary Device ID00384841732000
NIH Device Record Keyd353cb4d-bf1c-4a9b-940d-f9c0462fd87b
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdigy No Coding Blood Glucose Test Strips
Version Model Number75050
Catalog Number75050
Company DUNS832875905
Company NamePRODIGY DIABETES CARE, LLC
Device Count1
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 Numbertrue
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
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com
Phone1.800.243.2636
Emailcustomercare@prodigymeter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100384840750500 [Primary]
GS100384841732000 [Direct Marking]
NDC/NHRIC08484-0750-50 [Secondary]
GS130384840750501 [Package]
Contains: 00384840750500
Package: Corrugated Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-18
Device Publish Date2019-01-16

On-Brand Devices [Prodigy No Coding Blood Glucose Test Strips]

003848407530061 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
00384841732000Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.
003848447320071 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
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).
003848405280001 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
003848431040031 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct)

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