StatSensor 44037

GUDID 00385480440370

StatSensor Creat Linearity Level 1 - 5

NOVA BIOMEDICAL CORPORATION

Creatinine IVD, control

• Primary Device ID: 00385480440370
• NIH Device Record Key: 80b3f5d6-a320-41fe-b22c-33b942b47fe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatSensor
• Version Model Number: Creatinine
• Catalog Number: 44037
• Company DUNS: 070617139
• Company Name: NOVA BIOMEDICAL CORPORATION
• Device Count: 5
• 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: 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

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480440370 [Primary]
GS1	00385489440371 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070068

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [StatSensor]

• 10385480506684: StatSensor Creatinine Meter with Battery and Quick Reference Guide
• 10385480453353: StatSensor Creatinine Meter with Quick Reference Guide - Remanufactured
• 10385480440520: StatSensor Creatinine Meter with Battery and Quick Reference Guide
• 00385480440370: StatSensor Creat Linearity Level 1 - 5
• 00385480439237: StatSensor Creat Control Level 3
• 00385480439220: StatSensor Creat Control Level 2
• 00385480439213: StatSensor Creat Control Level 1