StatSensor 44052

GUDID 10385480440520

StatSensor Creatinine Meter with Battery and Quick Reference Guide

NOVA BIOMEDICAL CORPORATION

Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

• Primary Device ID: 10385480440520
• NIH Device Record Key: 48c6926e-4ba3-458a-be73-5c7202864577
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatSensor
• Version Model Number: 1.0
• Catalog Number: 44052
• 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: 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

• 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
• Special Storage Condition, Specify: Between 0 and 0 *Without Condensation
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling 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	00385480440523 [Primary]
GS1	10385480440520 [Package]; Contains: 00385480440523; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070068

FDA Product Code

• CGL: ELECTRODE, ION BASED, ENZYMATIC, CREATININE

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