Control™ Meter Kit IGM-G3-103

GUDID 00885502001041

U.S. DIAGNOSTICS INC.

Glucose monitoring system IVD, home-use
Primary Device ID00885502001041
NIH Device Record Keyf75e883f-fcf1-4c07-8d4b-1ce81062ef02
Commercial Distribution StatusIn Commercial Distribution
Brand NameControl™ Meter Kit
Version Model NumberIGM-0009
Catalog NumberIGM-G3-103
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 Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 Microliter
Total Volume1 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
GS100885502001041 [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 Date2017-10-26

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 [Control]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONTROL
CONTROL
98700278 not registered Live/Pending
KR Technologies, LLC
2024-08-15
CONTROL
CONTROL
98567105 not registered Live/Pending
GARCIA DE LA PENA, LAUTARO
2024-05-24
CONTROL
CONTROL
98128191 not registered Live/Pending
NGUYEN VENTURES LLC
2023-08-11
CONTROL
CONTROL
97340787 not registered Live/Pending
SERGIO DEGOLLADO
2022-03-31
CONTROL
CONTROL
97340787 not registered Live/Pending
GERALDINE DEGOLLADO
2022-03-31
CONTROL
CONTROL
97018668 not registered Live/Pending
The Retail Equation, Inc.
2021-09-09
CONTROL
CONTROL
90124643 not registered Live/Pending
Judson Brandeis
2020-08-19
CONTROL
CONTROL
90108876 not registered Live/Pending
UTAK Laboratories, Inc.
2020-08-12
CONTROL
CONTROL
87983422 not registered Live/Pending
Remedy Entertainment Oyj
2017-11-29
CONTROL
CONTROL
87950630 not registered Dead/Abandoned
FLYTLAB LLC
2018-06-06
CONTROL
CONTROL
87713806 not registered Live/Pending
Active Sports, Inc.
2017-12-08
CONTROL
CONTROL
87712170 not registered Live/Pending
Active Sports, Inc.
2017-12-07

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