NOVA MAX 44585

GUDID 10385480445853

Nova Max Link with Battery and Quick Reference Guide

NOVA BIOMEDICAL CORPORATION

Glucose monitoring system IVD, home-use

• Primary Device ID: 10385480445853
• NIH Device Record Key: a35d9e4a-494e-42d9-9a23-a60b6477f885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA MAX
• Version Model Number: Link
• Catalog Number: 44585
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

• Special Storage Condition, Specify: Between 0 and 0 *0 ft to 10000 ft
• Special Storage Condition, Specify: Between 0 and 0 *0 ft to 10000 ft

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480445856 [Primary]
GS1	10385480445853 [Package]; Contains: 00385480445856; Package: Carton [1 Units]; In Commercial Distribution
GS1	20385480445850 [Package]; Package: Carton [4 Units]; In Commercial Distribution

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-06
• Device Publish Date: 2016-09-20

On-Brand Devices [NOVA MAX]

• 00385480496407: Nova Max Plus Glu/Ket Control Solution - Mid
• 10385480458242: Nova Max Plus Blood Glucose Monitoring System
• 10385480445853: Nova Max Link with Battery and Quick Reference Guide
• 00385480434461: Nova Max Glucose Normal Glucose Control Solution
• 10385480434369: Nova Max Plus Blood Glucose Monitoring System
• 10385480434352: Nova Max Plus Plus Blood Glucose Monitoring System