FDA.reportPublic FDA data

CONTOUR®

Primary DI
10301937070256
Brand
CONTOUR®
Company
ASCENSIA DIABETES CARE US INC.
Model
7070A
Catalog number
6707105
Device description
Blood Glucose Test strips. 25 test strips.
Published
2016-09-16
Public version status
Update
Distribution status
Not 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
00301937070259PackageGS11Not in Commercial Distribution
40301937070257PackageGS124Not in Commercial Distribution
40301939725254PackageGS124Not in Commercial Distribution
10301937070256PrimaryGS10
0193-7070-25SecondaryNDC/NHRIC0
00301937070013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00301937070259003019370702593019370702590301937070259
4030193707025740301937070257
4030193972525440301939725254
1030193707025610301937070256
00301937070013003019370700133019370700130301937070013

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, Specify00
Special Storage Condition, Specify00Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip.
Storage Environment Temperature48 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
080028910
Device count
25
Lot or batch
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

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Primary DI, Brand, Company table
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20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
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10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
40301939660517CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXTASCENSIA DIABETES CARE US INC.LFR2022-11-23
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10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
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