DEVICE: ReDS Wearable System (07290110070021)
Device Identifier (DI) Information
ReDS Wearable System
V2.6
In Commercial Distribution
PAK0009
SENSIBLE MEDICAL INNOVATIONS LTD
V2.6
In Commercial Distribution
PAK0009
SENSIBLE MEDICAL INNOVATIONS LTD
Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Wearable System)
Device Characteristics
MR Conditional | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35242 | Whole-body plethysmograph |
A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DSB | Plethysmograph, Impedance |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150095 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
10b1698b-ac74-4328-8fc3-d7e099b84a3f
July 06, 2018
3
September 01, 2016
July 06, 2018
3
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
855.899.7951
customersupport@sensible-medical.com
customersupport@sensible-medical.com