DEVICE: StatStrip (00385480434041)

Device Identifier (DI) Information

StatStrip
Xpress
In Commercial Distribution
43404
NOVA BIOMEDICAL CORPORATION
00385480434041
GS1

1
070617139 *Terms of Use
StatStrip Xpress Glucose Meter and Quick Reference Guide
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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, point-of-care A collection of devices including a portable, battery-powered, semi-automated or automated instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose in a whole blood clinical specimen. 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
CGA GLUCOSE OXIDASE, GLUCOSE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150461 000
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Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 15 and 40 Degrees Celsius
Storage Environment Temperature: between 15 and 40 Degrees Celsius
Special Storage Condition, Specify: 0 ft to 15000 ft
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a92901d2-d5a5-4422-99c5-f599fc849651
July 06, 2018
3
September 20, 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
10385480434048 1 00385480434041 In Commercial Distribution Carton
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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
Yes
Yes
Yes
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Customer Contact

[?]
+1(800)545-6682
info@novabio.com
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