AccessGUDID - DEVICE: StatStrip (00385480437738)

GUDID

Device Identifier (DI) Information

Brand Name: StatStrip
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 43773
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480437738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: StatStrip GLU Meter and Quick Reference Guide Remanufactured

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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
No Device Sizes

Device Record Status

Public Device Record Key: 0f0f89e3-bdf3-4905-bef4-70952b8be5f4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 20, 2016