STATSTRIP 54790

GUDID 00385480547901

Statstrip Glucose Meter with Battery and Quick Reference Guide

NOVA BIOMEDICAL CORPORATION

Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care

• Primary Device ID: 00385480547901
• NIH Device Record Key: c1576f37-f7c6-47f1-ae79-9535e927d3c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATSTRIP
• Version Model Number: 1.86
• Catalog Number: 54790
• Company DUNS: 070617139
• Company Name: NOVA BIOMEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)545-6682
• Email: info@novabio.com
• Phone: +1(800)545-6682
• Email: info@novabio.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Without Condensation
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *0 ft to 15000 ft
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480547901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150281

FDA Product Code

• JJX: Single (specified) analyte controls (assayed and unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-09-16

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