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 ID07290110070113
NIH Device Record Key72fa7d68-6566-4a69-bdec-c24e278ab349
Commercial Distribution StatusIn Commercial Distribution
Brand NameReDS System
Version Model NumberV2.6
Catalog NumberSAS0120
Company DUNS532269045
Company NameSENSIBLE MEDICAL INNOVATIONS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855.899.7951
Emailcustomersupport@sensible-medic
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com
Phone855.899.7951
Emailcustomersupport@sensible-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110070113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSBPlethysmograph, Impedance

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-22

On-Brand Devices [ReDS System]

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

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