FDA.reportPublic FDA data

CONTOUR®

Primary DI
10301937080507
Brand
CONTOUR®
Company
ASCENSIA DIABETES CARE US INC.
Model
7080G
Catalog number
6707113
Device description
Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - RDC # 0193-7080-50).
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
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
K062058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062058000ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080Bayer Healthcare2006-09-11NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00301937080500PackageGS11In Commercial Distribution
00301937090219PackageGS12Not in Commercial Distribution
40301937080508PackageGS124In Commercial Distribution
40301937090217PackageGS112Not in Commercial Distribution
40301939602043PackageGS14Not in Commercial Distribution
40301939603040PackageGS14Not in Commercial Distribution
40301939726503PackageGS124Not in Commercial Distribution
40301939727210PackageGS112Not in Commercial Distribution
10301937080507PrimaryGS10
0193-7080-50SecondaryNDC/NHRIC0
00301937080012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00301937080500003019370805003019370805000301937080500
00301937090219003019370902193019370902190301937090219
4030193708050840301937080508
4030193709021740301937090217
4030193960204340301939602043
4030193960304040301939603040
4030193972650340301939726503
4030193972721040301939727210
1030193708050710301937080507
00301937080012003019370800123019370800120301937080012

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
Special Storage Condition, Specify00Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.
Storage Environment Temperature48 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
18003488100support@contournext.com

Regulatory Flags#

DUNS number
080028910
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00301937584503CONTOUR® PLUS7584900124792024-08-01

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10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
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