Duns Number:989925396
Device Description: The Integra Camino Flex Adapter is designed as an accessory to connect the Integra Camino The Integra Camino Flex Adapter is designed as an accessory to connect the Integra Camino Flex Catheters (Integra LifeSciences Corporation) with the Camino Advanced Monitor (CAM01) for the direct and continuous measurement of intracranial pressure (ICP). It is a reusable device with an accessory holder which allows the Integra Camino Flex Adapter to be permanently attached to the Camino Advanced Monitor.
Catalog Number
-
Brand Name
Camino®
Version/Model Number
FLEXADR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
K121159
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
d48acb45-01a2-4746-8037-df729fbbd854
Public Version Date
April 06, 2020
Public Version Number
4
DI Record Publish Date
December 29, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |
| U | Unclassified | 114 |