ReDS Pro System PAK0012

GUDID 07290110070151

Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Pro System)

SENSIBLE MEDICAL INNOVATIONS LTD

Whole-body plethysmograph

• Primary Device ID: 07290110070151
• NIH Device Record Key: 4b511ad8-76d1-4ad1-be01-3d26fb067ad1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReDS Pro System
• Version Model Number: V2.7
• Catalog Number: PAK0012
• 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: 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: 8558997951
• Email: customersupport@sensible-medical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110070151 [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: 2019-06-19
• Device Publish Date: 2019-06-11

On-Brand Devices [ReDS Pro System]

• 07290110070151: Empty package, to enable a replacement of damaged package or a return shipment to the manufactur
• 07290110070144: Fluid status monitor This catalog item is used by a health care provider in the hospital, hospit
• 07290110070267: Fluid status monitor This catalog item is used by a health care provider in the hospital, hospit
• 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