Duns Number:160990313
Device Description: RenovaRP Tube Set from GI Supply is intended to be used in conjunction with the RenovaRP P RenovaRP Tube Set from GI Supply is intended to be used in conjunction with the RenovaRP Paracentesis Management System to remove ascitic fluid from the abdominal cavity
Catalog Number
GIS-30
Brand Name
RenovaRP Tube Set
Version/Model Number
GIS-30
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"
-
For Single-Use
Yes
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
K970187,K970187
Product Code
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
0f2146df-41e9-4913-91aa-b69d47df1e70
Public Version Date
August 18, 2022
Public Version Number
1
DI Record Publish Date
August 10, 2022
Package DI Number
10893029002165
Quantity per Package
5
Contains DI Package
00893029002168
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |