DEVICE: StatSensor/StatStrip (00385480519953)

Device Identifier (DI) Information

StatSensor/StatStrip
1.0
In Commercial Distribution
51995
NOVA BIOMEDICAL CORPORATION
00385480519953
GS1

1
070617139 *Terms of Use
Statsensor Statstrip Docking Station 2 position
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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
Home-use/point-of-care blood glucose monitoring system IVD 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 together for testing, either at the point-of-care or self-testing by a layperson, 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
KHP ACID, LACTIC, ENZYMATIC METHOD
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
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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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

46619582-ef93-4d81-a1df-f0e4c00a453d
March 29, 2018
2
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
10385480519950 1 00385480519953 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

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(180)054-5668
info@novabio.com
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