ReDS Pro System GAS0047

GUDID 07290110070243

Fluid status monitor This catalog item is used by a health care provider in the hospital, hospital like facilities and home setting

SENSIBLE MEDICAL INNOVATIONS LTD

Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph

• Primary Device ID: 07290110070243
• NIH Device Record Key: 80cf39f3-701d-4269-818e-838d3eff3790
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReDS Pro System
• Version Model Number: V2.7
• Catalog Number: GAS0047
• Company DUNS: 532269045
• Company Name: SENSIBLE MEDICAL INNOVATIONS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com
• Phone: 855.899.7951
• Email: customersupport@sensible-medical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110070243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180479

FDA Product Code

• DSB: Plethysmograph, Impedance

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: 2020-07-10
• Device Publish Date: 2020-07-02

On-Brand Devices [ReDS Pro System]

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• 07290110070243: Fluid status monitor This catalog item is used by a health care provider in the hospital, hospit
• 07290110070540: Fluid status monitor This catalog item is used by a health care provider in the hospital, hospit
• 07290110070328: Fluid status monitor This catalog item is used by a health care provider in the hospital, hospit