Duns Number:160990313
Device Description: RenovaRP Fluid Drainage Bag to be used with RenovaRP Paracentesis Pump - sold in box of 20
Catalog Number
GIS-29
Brand Name
RenovaRP Fluid Drainage Bag
Version/Model Number
GIS-29
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K970187,K970187
Product Code
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
5df67407-7675-4c3c-8a7c-3060a5f240af
Public Version Date
July 15, 2021
Public Version Number
1
DI Record Publish Date
July 07, 2021
Package DI Number
10893029002158
Quantity per Package
20
Contains DI Package
00893029002151
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box of 20
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |