CONTOUR® NEXT LINK 9632

GUDID 40301939632019

Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; MICROLET® 2 Lancing Device; Alternative Site Endcap; Adjustable Endcap; 25 Lancets (provided sterile); Quick Reference Guide; Wall Charger; User Guide; USB Extension Cable; Logbook; Carrying Case.

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use
Primary Device ID40301939632019
NIH Device Record Keyda1d6479-4be4-44b9-a3cf-3f4f0c1ad177
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONTOUR® NEXT LINK
Version Model Number9632
Catalog Number9632
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone18003488100
Emailsupport@contournext.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100301939632011 [Primary]
GS140301939632019 [Package]
Contains: 00301939632011
Package: shipper/case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-16

On-Brand Devices [CONTOUR® NEXT LINK]

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40301939632019Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR
40301939624014Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR
40301936207012Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR
40301936203014Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR
40301936201010Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR

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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