Sensica UO System SSPK1025

GUDID 10801741215640

Sensica UO System Ring - ICU

C. R. Bard, Inc.

Urine monitoring system

• Primary Device ID: 10801741215640
• NIH Device Record Key: baef5955-3544-427d-bd95-e526bf435a69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensica UO System
• Version Model Number: SSPK1025
• Catalog Number: SSPK1025
• 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.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 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741215643 [Primary]
GS1	10801741215640 [Package]; Contains: 00801741215643; 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