Duns Number:989925396
Device Description: Use only Integra-supplied 14.4 V lithium ion battery for LICOX and CAMINO monitors. Charge Use only Integra-supplied 14.4 V lithium ion battery for LICOX and CAMINO monitors. Charge time = No more than 5 hours, while the monitor is plugged into an AC power outlet and the monitor is turned off. Operation time = 1.5 hours.
Catalog Number
-
Brand Name
Camino®
Version/Model Number
BAT1001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
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
K121573
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
cf1a6fc5-3f67-4191-9821-cc9f80ebe246
Public Version Date
February 11, 2019
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 |