CONTOUR® Plus Blue 90006207

GUDID 00301937035012

"For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Blue blood glucose meter (Product of Indonesia) -10 Contour Plus blood glucose test strips (Product of Japan) -Microlet Next lancing device (Product of Poland) -10 Microlet lancets (Product of Poland) -User Guide -Quick Reference Guide -Carrying Case (Product of China) Contour Plus control solution (Product of USA)"

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use
Primary Device ID00301937035012
NIH Device Record Keyc8c4e4f9-f40a-4f64-96cd-92a4372ff8d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONTOUR® Plus Blue
Version Model Number7035
Catalog Number90006207
Company DUNS080028910
Company NameASCENSIA DIABETES CARE US 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 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

Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100301937035012 [Primary]
GS140301937035010 [Package]
Package: shipper/case [4 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 Date2024-06-07
Device Publish Date2024-05-30

On-Brand Devices [CONTOUR® Plus Blue]

00301937035012"For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Bl
40301937036017"Contour Plus Blue Blood Glucose monitoring System For Self- testing, mornitoring and management

Trademark Results [CONTOUR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
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98571821 not registered Live/Pending
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2024-05-28
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2024-02-02
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2023-12-04
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2023-12-03
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2023-11-25
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2023-11-01
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98235446 not registered Live/Pending
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2023-10-23
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98126123 not registered Live/Pending
Helm Agro US, Inc.
2023-08-10
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98113404 not registered Live/Pending
Prollenium Medical Technologies, Inc.
2023-08-02
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98092158 not registered Live/Pending
Tulster, LLC
2023-07-19
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98038281 not registered Live/Pending
Singer Sourcing Limited LLC
2023-06-12
CONTOUR
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97841816 not registered Live/Pending
Ridgeline International, Inc.
2023-03-16

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