CONTOUR® NEXT ONE 90007939

GUDID 40301937825017

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; MICROLET® NEXT Lancing Device; 10 MICROLET® Lancets; User Guide; Quick Reference Guide; Carrying Case

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use
Primary Device ID40301937825017
NIH Device Record Keyd80a934d-1b50-4a26-bd3e-fa658fb19011
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONTOUR® NEXT ONE
Version Model Number7825
Catalog Number90007939
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

Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
Emailsupport@contournext.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100301937825019 [Primary]
NDC/NHRIC0193-7825-01 [Secondary]
GS140301937825017 [Package]
Contains: 00301937825019
Package: shipper/case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-30
Device Publish Date2021-11-22

On-Brand Devices [CONTOUR® NEXT ONE]

40301939767018Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
40301939765014Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
40301939763010Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
40301937824010Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
00301937818011Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
40301939766011Kit contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit; MICROLET® NEXT Lancing De
40301937825017Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
40301939550016Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
40301937828018Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g

Trademark Results [CONTOUR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONTOUR
CONTOUR
98388200 not registered Live/Pending
Scientific Games, LLC
2024-02-02
CONTOUR
CONTOUR
98297430 not registered Live/Pending
Automatic Devices Company
2023-12-04
CONTOUR
CONTOUR
98296265 not registered Live/Pending
Tessaract Materials Inc
2023-12-03
CONTOUR
CONTOUR
98285099 not registered Live/Pending
Tessaract Materials Inc
2023-11-25
CONTOUR
CONTOUR
98250537 not registered Live/Pending
Pinta Elements GmbH
2023-11-01
CONTOUR
CONTOUR
98235446 not registered Live/Pending
Landscape Forms, Inc.
2023-10-23
CONTOUR
CONTOUR
98126123 not registered Live/Pending
Helm Agro US, Inc.
2023-08-10
CONTOUR
CONTOUR
98113404 not registered Live/Pending
Prollenium Medical Technologies, Inc.
2023-08-02
CONTOUR
CONTOUR
98092158 not registered Live/Pending
Tulster, LLC
2023-07-19
CONTOUR
CONTOUR
98038281 not registered Live/Pending
Singer Sourcing Limited LLC
2023-06-12
CONTOUR
CONTOUR
97841816 not registered Live/Pending
Ridgeline International, Inc.
2023-03-16
CONTOUR
CONTOUR
97738668 not registered Live/Pending
Kent Nutrition Group, Inc.
2023-01-01

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