DEVICE: STATSTRIP (00385480533980)

Device Identifier (DI) Information

STATSTRIP
1.75
In Commercial Distribution
53398
NOVA BIOMEDICAL CORPORATION
00385480533980
GS1

1
070617139 *Terms of Use
Statstrip Glucose Meter with Battery 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

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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, 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

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Product Code Product Code Name
CGA GLUCOSE OXIDASE, GLUCOSE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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 15 and 40 Degrees Celsius
Handling Environment Temperature: between 15 and 40 Degrees Celsius
Special Storage Condition, Specify: 0 ft to 15000 ft
Special Storage Condition, Specify: Without Condensation
Storage Environment Humidity: between 0 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

77a905a0-bcf3-453e-a163-7becb7cb7672
March 29, 2018
2
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

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

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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