Duns Number:989925396
Device Description: The Integra PAC1 cable is intended for use with Camino CAM01 and MPM monitors and Camino F The Integra PAC1 cable is intended for use with Camino CAM01 and MPM monitors and Camino Flex catheter products to support the direct and continuous measurement of intracranial pressure (ICP) and intracranial temperature (ICT) when connected to the MPM or Camino CAM01 intracranial pressure ICP monitor. The device is a reusable product.
Catalog Number
-
Brand Name
Camino®
Version/Model Number
PAC1
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
-
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
21fc6398-f933-4792-8cf6-e0b499111d1f
Public Version Date
April 06, 2020
Public Version Number
3
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 |