NOVA MAX 49640

GUDID 00385480496407

Nova Max Plus Glu/Ket Control Solution - Mid

NOVA BIOMEDICAL CORPORATION

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 00385480496407
• NIH Device Record Key: 7b03d5f9-9688-4e45-8237-37083e441b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA MAX
• Version Model Number: Plus
• Catalog Number: 49640
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480496407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101633

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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: 2018-07-06
• 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