FDA.report

CONTOUR® NEXT ONE

Primary DI
40301939766011
Brand
CONTOUR® NEXT ONE
Company
ASCENSIA DIABETES CARE US INC.
Model
9766
Catalog number
9766
Device description
Kit contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit; MICROLET® NEXT Lancing Device; 4 bags of MICROLET® lancets (25 per bag; provided
Published
2017-02-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications

CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Premarket Submissions

SubmissionSupplement
K160682000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K160682000CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care2016-11-17NBW

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40301939766011PrimaryGS10

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature48 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1-855-691-6532support@contournext.com

Regulatory Flags

DUNS number
080028910
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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