Duns Number:989925396
Device Description: On LICOX monitors, Data Streaming Enabled Indicates that the feature for streaming patient On LICOX monitors, Data Streaming Enabled Indicates that the feature for streaming patient trend data digitally to another media type has been activated. This feature requires the use ofthe USB-to-RS232 adapter cable.
Catalog Number
EXPORTCAB
Brand Name
Camino®
Version/Model Number
EXPORTCAB
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
c7a54856-bba2-42e3-80ba-65adacbe8747
Public Version Date
October 04, 2022
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 |