FDA.reportPublic FDA data

CONTOUR® NEXT ONE

Primary DI
00301937828010
Brand
CONTOUR® NEXT ONE
Company
ASCENSIA DIABETES CARE US INC.
Model
7828
Catalog number
90007942
Device description
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.Kit contains: CONTOUR® NEXT ONE Meter; 20 CONTOUR® NEXT Blood Glucose Test Strips; MICROLET® NEXT Lancing Device; 20 MICROLET® Lancets; User Guide; Quick Reference Guide; Carrying Case
Published
2022-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFRGlucose Dehydrogenase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210687000CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care2021-08-11NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40301937828018PackageGS14In Commercial Distribution
00301937828010PrimaryGS10
0193-7828-01SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4030193782801840301937828018
00301937828010003019378280103019378280100301937828010

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1 (800) 348-8100support@contournext.com

Regulatory Flags#

DUNS number
080028910
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10301937080507CONTOUR®7080G67071132016-09-16
00301936260019CONTOUR® NEXT LINK 2.46260819146722016-08-25
00301936020217MICROLET® NEXT6020900122812026-03-16
00301936021214MICROLET® NEXT6021900122822026-03-16
40301936020215MICROLET® NEXT6020900122812026-03-16
40301936021212MICROLET® NEXT6021900122822026-03-16
10301937277358CONTOUR® NEXT7277857231542017-11-03
10301937278706CONTOUR® NEXT7278857012312017-11-03
00301936262013CONTOUR® NEXT LINK 2.46262850929792016-08-25
00301939658011CONTOUR® NEXT GEN9658900029042022-06-30
00301937035029CONTOUR® PLUS BLUE7035900062072025-01-06
10301937309509CONTOUR® NEXT7309836230802016-08-25
10301937310253CONTOUR® NEXT7310836230992016-08-25
10301937311502CONTOUR® NEXT7311836247102016-08-25
10301937312219CONTOUR® NEXT7312836247882016-08-25
10301937314015CONTOUR® NEXT7314836248182016-09-16
10301937315012CONTOUR® NEXT7315836248262016-09-16
10301937550154CONTOUR®NEXT7550900011742019-08-30
00301937036019CONTOUR® PLUS BLUE7036900083812024-08-01
00301937383014CONTOUR® NEXT GEN7383900048502022-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
40301939660517CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXTASCENSIA DIABETES CARE US INC.LFR2022-11-23
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19