NOVA MAX 43446

GUDID 00385480434461

Nova Max Glucose Normal Glucose Control Solution

NOVA BIOMEDICAL CORPORATION

Glucose IVD, control Glucose IVD, control

• Primary Device ID: 00385480434461
• NIH Device Record Key: feed8865-10e2-4f63-a55b-3c4fc57e1760
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA MAX
• Version Model Number: GLU
• Catalog Number: 43446
• 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: false
• 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

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480434461 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

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• 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