INFINITY™ Meter Kit G5-103MK

GUDID 00885502001003

U.S. DIAGNOSTICS INC.

Glucose monitoring system IVD, home-use
Primary Device ID00885502001003
NIH Device Record Key11cedb29-7f3e-4b6a-a9d3-32c74ed7af1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFINITY™ Meter Kit
Version Model NumberIGM-0024
Catalog NumberG5-103MK
Company DUNS828116728
Company NameU.S. DIAGNOSTICS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net
Phone866-216-5308
Emailjkupar@usdiagnostics.net

Device Dimensions

Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100885502001003 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-13

Devices Manufactured by U.S. DIAGNOSTICS INC.

10885502002007 - INFINITY™ Test Strips2024-11-11
00885502002031 - EasyGluco™G2 Test Strips2024-11-11
10885502002045 - Control™ Test Strips2024-11-11
00885502004004 - INFINITY™ Normal Control Solution2018-10-25
00885502004035 - EasyGluco™ Normal Control Solution2018-10-25
00885502015000 - INFINITY™ Low Control Solution2018-10-25
00885502015031 - EasyGluco™ Low Control Solution2018-10-25
00885502016007 - INFINITY™ High Control Solution2018-10-25

Trademark Results [INFINITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INFINITY
INFINITY
98761246 not registered Live/Pending
Zevex, Inc.
2024-09-20
INFINITY
INFINITY
98737979 not registered Live/Pending
Marten Group, Inc.
2024-09-06
INFINITY
INFINITY
98643936 not registered Live/Pending
Project Management Institute, Inc.
2024-07-11
INFINITY
INFINITY
98470220 not registered Live/Pending
IBF IP, LLC
2024-03-27
INFINITY
INFINITY
98466286 not registered Live/Pending
IBF IP, LLC
2024-03-25
INFINITY
INFINITY
98454204 not registered Live/Pending
Tanks By Mail Inc
2024-03-18
INFINITY
INFINITY
98433629 not registered Live/Pending
Infinity Generation Inc.
2024-03-05
INFINITY
INFINITY
98338571 not registered Live/Pending
Careismatic Brands, LLC
2024-01-02
INFINITY
INFINITY
98293120 not registered Live/Pending
PREFERRED COLLECTIONS INC.
2023-11-30
INFINITY
INFINITY
98275942 not registered Live/Pending
Capital One Financial Corporation
2023-11-17
INFINITY
INFINITY
98242984 not registered Live/Pending
IGH Holding Inc.
2023-10-27
INFINITY
INFINITY
98175956 not registered Live/Pending
CellFE, Inc.
2023-09-12

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