FDA.reportPublic FDA data

CONTOUR® NEXT

Primary DI
10301937315012
Brand
CONTOUR® NEXT
Company
ASCENSIA DIABETES CARE US INC.
Model
7315
Catalog number
83624826
Device description
Control Solution - Level 1. 1 x 2.5 mL.
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121190000
K151742000
K160430000
K160682000
K162336000
K191286000
K193407000
K210687000
K223293000
K241787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121190000CONTOUR NEXT BLOOD GLUCOSE METERBayer Healthcare, LLC2012-07-26LFR
K151742000Contour Next Control SolutionBayer Healthcare2015-09-23JJX
K160430000Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.2016-06-24NBW
K160682000CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care2016-11-17NBW
K162336000Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.2017-01-12NBW
K191286000CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring SystemAscensia Diabetes Care2019-11-08NBW
K193407000Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care2021-12-23NBW
K210687000CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care2021-08-11NBW
K223293000CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.2022-11-18NBW
K241787000CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.2024-08-27NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00301937315015PackageGS11In Commercial Distribution
40301937315013PackageGS112In Commercial Distribution
50301937315010PackageGS132In Commercial Distribution
10301937315012PrimaryGS10
0193-7315-01SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00301937315015003019373150153019373150150301937315015
4030193731501340301937315013
5030193731501050301937315010
1030193731501210301937315012

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, Specify00Do 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
1
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
10301937550154CONTOUR®NEXT7550900011742019-08-30
00301937036019CONTOUR® PLUS BLUE7036900083812024-08-01
00301937383014CONTOUR® NEXT GEN7383900048502022-06-30
00301937584503CONTOUR® PLUS7584900124792024-08-01

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