Duns Number:160990313
Device Description: Large Volume Paracentesis Kit. The GI Supply RenovaRP Paracentesis Kit is intended to be u Large Volume Paracentesis Kit. The GI Supply RenovaRP Paracentesis Kit is intended to be used in conjunction with the GI Supply Renova RP Paracentesis Pump and GI Supply RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity. The GI Supply RenovaRP Paracentesis Kit is intended to be used medically trained healthcare professionals knowledgeable about paracentesis.
Catalog Number
GIS-32
Brand Name
RenovaRP Paracentesis Kit
Version/Model Number
GIS-32
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
0382a97a-7369-431c-b7ba-01c6c6d12478
Public Version Date
July 14, 2021
Public Version Number
1
DI Record Publish Date
July 06, 2021
Package DI Number
10893029002172
Quantity per Package
5
Contains DI Package
00893029002175
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit
| 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 |