DEVICE: CONTOUR® (00301939556010)

Device Identifier (DI) Information

CONTOUR®
9556C
In Commercial Distribution
9556C
ASCENSIA DIABETES CARE US INC.
00301939556010
GS1

1
080028910 *Terms of Use
Blood Glucose Monitoring System. For self-testing, monitoring and management of blood glucose. Contents: CONTOUR® Blood Glucose Meter; Quick Reference Guide; User Guide; Log Book; Carrying Case; Warranty Card.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Glucose monitoring system IVD, home-use A 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LFR Glucose Dehydrogenase, Glucose
NBW System, Test, Blood Glucose, Over The Counter
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062058 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

e898a698-5244-4623-9f3c-89c2f8479065
July 06, 2018
3
September 16, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
40301939556018 4 00301939556010 In Commercial Distribution shipper/case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
NDC/NHRIC 0193-9556-01
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
18003488100
support@contournext.com
CLOSE