CONTOUR® NEXT EZ and CONTOUR® NEXT 5534

GUDID 40301935534515

Mixed product shipper case containing 6 CONTOUR® NEXT EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014) and 12 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Primary DI Number 10301937308502).

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use
Primary Device ID40301935534515
NIH Device Record Key484b12ff-11bd-46e7-99eb-de6b25cbf71c
Commercial Distribution Discontinuation2018-06-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCONTOUR® NEXT EZ and CONTOUR® NEXT
Version Model Number5534
Catalog Number5534
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 Kitfalse
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

Phone1-800-348-8100
Emailsupport@contournext.com
Phone1-800-348-8100
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
GS140301935534515 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-12-16

Devices Manufactured by ASCENSIA DIABETES CARE US INC.

40301937036017 - CONTOUR® Plus Blue2024-08-09 "Contour Plus Blue Blood Glucose monitoring System For Self- testing, mornitoring and management of blood glucose. Kit Contains:
40301937584501 - Contour Plus2024-08-09 Blood Glucose Test Strips. 50 test strips.
40301937593015 - Contour Plus2024-08-09 Control Solution - Level 1. 1 x 2.5 mL.
40301937594012 - Contour Plus2024-08-09 Control Solution - Level 2. 1 x 2.5 mL.
00301937035012 - CONTOUR® Plus Blue2024-06-07 "For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Blue blood glucose meter (Product
20301939563104 - CONTOUR® Plus2024-06-07 For Self-Testing For use with the CONTOUR® Plus BLUE meter
40301937922013 - CONTOUR® NEXT GEN2023-07-31 "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing D
40301939732016 - CONTOUR® NEXT GEN2023-07-31 "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOU

Trademark Results [CONTOUR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONTOUR
CONTOUR
98571821 not registered Live/Pending
Corning Optical Communications LLC
2024-05-28
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.