Duns Number:531408342
Device Description: The Camino Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct The Camino Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct and continuous intraventricular intracranial pressure monitoring and cerebrospinal fluid drainage are required. The catheter is embedded with a strain gauge pressure transducer.The system is designed for no more than five days of continuous monitoring.
Catalog Number
-
Brand Name
Camino®
Version/Model Number
VTUN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2019
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133754,K133754
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
cc9de073-5a5d-43df-816b-7159ec317de2
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
August 04, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |