DEVICE: CONTOUR®NEXT (10301937550154)

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Device Record History
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Device Identifier (DI) Information
CONTOUR®NEXT
7550
In Commercial Distribution
90001174
ASCENSIA DIABETES CARE US INC.
10301937550154
GS1

1
080028910 *Terms of Use
Blood glucose test strips. Sold in a carton of 15 test strips.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62537 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OZP Automated Insulin Dosing Device System, Single Hormonal Control
OZO Automated Insulin Dosing , Threshold Suspend
NBW System, Test, Blood Glucose, Over The Counter
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K191286 000
K193407 000
K210687 000
K223293 000
K241787 000
P150001 066
P160017 062
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 48 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
c1943aef-2a71-4eb5-a589-890a2ab034de
April 01, 2025
5
August 30, 2019
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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
40301937550155 24 00301937550157 In Commercial Distribution shipper/case
00301937550157 15 10301937550154 In Commercial Distribution carton
00301937550065 6 00301937550157 In Commercial Distribution shelf organizer
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-348-8100
support@contournext.com
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