DEVICE: StatStrip (00385480437738)
Device Identifier (DI) Information
StatStrip
1.0
In Commercial Distribution
43773
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution
43773
NOVA BIOMEDICAL CORPORATION
StatStrip GLU Meter and Quick Reference Guide Remanufactured
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJX | Single (specified) analyte controls (assayed and unassayed) |
CGA | GLUCOSE OXIDASE, GLUCOSE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Without Condensation |
Storage Environment Temperature: between 15 and 40 Degrees Celsius |
Special Storage Condition, Specify: 0 ft to 15000 ft |
Handling Environment Temperature: between 15 and 40 Degrees Celsius |
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0f0f89e3-bdf3-4905-bef4-70952b8be5f4
March 29, 2018
2
September 20, 2016
March 29, 2018
2
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10385480437735 | 1 | 00385480437738 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com