Sensica UO System SCCS1001

GUDID 00801741215612

Sensica UO System ICU

C. R. Bard, Inc.

Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system Urine monitoring system

• Primary Device ID: 00801741215612
• NIH Device Record Key: 5830e91d-f01e-41ef-95b6-a03f302a317e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensica UO System
• Version Model Number: SCCS1001
• Catalog Number: SCCS1001
• Company DUNS: 016898496
• Company Name: C. R. Bard, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CS.support@bd.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 83 KiloPascal and 103 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741215612 [Primary]

FDA Product Code

• EXS: URINOMETER, ELECTRICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-24
• Device Publish Date: 2021-06-16

On-Brand Devices [Sensica UO System]

• 00801741219016: SensicaUOMonitorEval
• 00801741215773: SensicaUrineOutputSystem
• 20801741215746: Sensica UO System Temperature Sensor Cable
• 10801741215657: Sensica UO System Temperature Monitor Module
• 10801741215763: Sensica Tube Band Positioning Strip - OR
• 10801741215756: Sensica UO Ring System - OR
• 10801741215732: Sensica Tube Band Positioning Strip - ICU
• 10801741215640: Sensica UO System Ring - ICU
• 00801741215612: Sensica UO System ICU
• 10801741218498: Sensica UO System Temperature Monitor Module for Evaluation