ReDS System GAS0035-R

GUDID 07290110070281

Fluid Status Monitor

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: 07290110070281
• NIH Device Record Key: 3064f2f8-5001-400d-b682-5c3b2e9dcb5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReDS System
• Version Model Number: V2.6
• Catalog Number: GAS0035-R
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 32 Degrees Celsius and 122 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110070281 [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: 2020-08-26
• Device Publish Date: 2020-08-18

On-Brand Devices [ReDS System]

• 07290110070113: Clinicl Kit including magnet, pins and caps for vest adjustment locking, to enable shipment of
• 07290110070106: Empty package, to enable a replacement of damaged package or a return shipment to the manufactu
• 07290110070090: Fluid Status Monitor
• 07290110070281: Fluid Status Monitor