ReDS System SAS0120

GUDID 07290110070113

Clinicl Kit including magnet, pins and caps for vest adjustment locking, to enable shipment of extra parts to the clinic (Related to ReDS Wearable Sy

SENSIBLE MEDICAL INNOVATIONS LTD

Whole-body plethysmograph

• Primary Device ID: 07290110070113
• NIH Device Record Key: 72fa7d68-6566-4a69-bdec-c24e278ab349
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReDS System
• Version Model Number: V2.6
• Catalog Number: SAS0120
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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-medic

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110070113 [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: 2017-08-22

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