ReDS Wearable System GAS0035

GUDID 07290110070014

Fluid Status Monitor

SENSIBLE MEDICAL INNOVATIONS LTD

Whole-body plethysmograph

• Primary Device ID: 07290110070014
• NIH Device Record Key: 0a69595a-4b02-4ea1-aac7-1a698b29b3a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReDS Wearable System
• Version Model Number: V2.6
• Catalog Number: GAS0035
• Company DUNS: 532269045
• Company Name: SENSIBLE MEDICAL INNOVATIONS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: 855.899.7951
• Email: customersupport@sensible-medic

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 42 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110070014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150095

FDA Product Code

• DSB: Plethysmograph, Impedance

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [ReDS Wearable System ]

• 07290110070038: Clinicl Kit including magnet, pins and caps for vest adjustment locking, to enable shipment of
• 07290110070021: Empty package, to enable a replacement of damaged package or a return shipment to the manufactu
• 07290110070014: Fluid Status Monitor