Duns Number:532269045
Device Description: Fluid status monitor This catalog item is used by a health care provider in the hospital, Fluid status monitor This catalog item is used by a health care provider in the hospital, hospital like facilities and home setting
Catalog Number
GAS0047
Brand Name
ReDS Pro System
Version/Model Number
V2.7
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K180479
Product Code
DSB
Product Code Name
Plethysmograph, Impedance
Public Device Record Key
80cf39f3-701d-4269-818e-838d3eff3790
Public Version Date
July 10, 2020
Public Version Number
1
DI Record Publish Date
July 02, 2020
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 |