StatStrip

Basic Information

• Brand Name: StatStrip
• Primary DI: 00385480434041
• Version / Model: Xpress
• Catalog Number: 43404
• Company Name: NOVA BIOMEDICAL CORPORATION
• Labeler DUNS: 070617139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: a92901d2-d5a5-4422-99c5-f599fc849651

Device Description

StatStrip Xpress Glucose Meter and Quick Reference Guide

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62538	Glucose monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered 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 singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10385480434048	GS1	Carton	1	In Commercial Distribution
Primary	00385480434041	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150461	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: 0 ft to 15000 ft
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity