Duns Number:532269045
Device Description: Empty package, to enable a replacement of damaged package or a return shipment to the man Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Wearable System)
Catalog Number
PAK0009
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
3de0b6cc-78bd-4fce-9587-9cd5def911b9
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 |