Duns Number:532269045
Device Description: Clinicl Kit including magnet, pins and caps for vest adjustment locking, to enable shipme Clinicl Kit including magnet, pins and caps for vest adjustment locking, to enable shipment of extra parts to the clinic (Related to ReDS Wearable System).
Catalog Number
SAS0120
Brand Name
ReDS System
Version/Model Number
V2.6
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150095
Product Code
DSB
Product Code Name
Plethysmograph, Impedance
Public Device Record Key
72fa7d68-6566-4a69-bdec-c24e278ab349
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 22, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |