Sensica UO System SROR1025

GUDID 10801741215756

Sensica UO Ring System - OR

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: 10801741215756
• NIH Device Record Key: 8faeedf5-0d9c-4aed-939b-a3fa7ec8a00b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensica UO System
• Version Model Number: SROR1025
• Catalog Number: SROR1025
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com
• Phone: +1(844)823-5433
• Email: BMD.CA.support@bd.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741215759 [Primary]
GS1	10801741215756 [Package]; Contains: 00801741215759; Package: CA [25 Units]; In Commercial Distribution

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