DEVICE: CONTOUR® NEXT (00301937283352)

Device Identifier (DI) Information

CONTOUR® NEXT
7283
In Commercial Distribution
7283
ASCENSIA DIABETES CARE US INC.
00301937283352
GS1

35
080028910 *Terms of Use
Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)). Formerly distributed in the USA by Bayer HealthCare; now distributed by Ascensia Diabetes Care US, Inc.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
OZO Artificial Pancreas Device System, Threshold Suspend
NBW System, Test, Blood Glucose, Over The Counter
LFR Glucose Dehydrogenase, Glucose
OZP Artificial Pancreas Device System, Single Hormonal Control
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121190 000
K160430 000
K162336 000
P150001 000
P160017 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Store test strips in their original bottle only. Always close the lid immediately and tightly after removing a test strip. Do not use after expiration date.
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

b1653fc7-fb56-4f31-b79e-5f24d1376209
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
40301937283350 12 00301937283352 In Commercial Distribution shipper/case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
NDC/NHRIC 0193-7283-35
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00301937283017 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
18003488100
support@contournext.com
CLOSE