Duns Number:989925396
Device Description: The ICT adaptor cable is a medical device accessory designed to support the interconnectio The ICT adaptor cable is a medical device accessory designed to support the interconnection of the Integra Camino series of monitors to 3rd party manufacturer bedside monitors in the non-sterile field. The reusable device consists of a signal connector (PMIO end), compatible with the Integra PMIOMPM-1 cable and a signal connector (monitor end) compatible with the 3rd party bedside monitor. The cable is provided non-sterile.
Catalog Number
ICT-39
Brand Name
Camino®
Version/Model Number
ICT-39
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"
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
2e921b56-1201-492e-9851-ae30c5c57494
Public Version Date
October 21, 2022
Public Version Number
4
DI Record Publish Date
April 14, 2017
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 |