DEVICE: CONTOUR® NEXT EZ (00301939628014)

Device Identifier (DI) Information

CONTOUR® NEXT EZ
9628
In Commercial Distribution
9628
ASCENSIA DIABETES CARE US INC.
00301939628014
GS1

1
080028910 *Terms of Use
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. This kit contains the following items: CONTOUR® Next EZ Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case.
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Device Characteristics

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

GMDN

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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.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K111268 000
K130265 000
K162336 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 48 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

40e2d11c-e161-4513-bdff-54bf7d96ef14
July 06, 2018
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
40301939628012 4 00301939628014 In Commercial Distribution shipper/case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
NDC/NHRIC 0193-9628-01
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
18003488100
support@contournext.com
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