Duns Number:694699723
Device Description: The peristaltic pump, VIVA Pump, is used to provide the cooling of the electrodes, star RF The peristaltic pump, VIVA Pump, is used to provide the cooling of the electrodes, star RF Electrode. The chilled water is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is enclosed system within the electrode and the water is not to be in contact with the patient.
Catalog Number
VP01
Brand Name
VIVA Pump
Version/Model Number
VP01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 04, 2019
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
-
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
K163450
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
10e7dd4d-e5f1-414f-8254-5061015e0e21
Public Version Date
July 05, 2019
Public Version Number
5
DI Record Publish Date
May 19, 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. | 8 |