Duns Number:480186617
Device Description: Patient Monitor Interface Cable - GE Datex-Ohmeda (11 Pin)
Catalog Number
82-6884
Brand Name
CereLink™
Version/Model Number
826884
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
K152670
Product Code
GWM
Product Code Name
Device, monitoring, intracranial pressure
Public Device Record Key
8723b228-ecf0-4a80-bcb4-d29a2ba3e409
Public Version Date
October 03, 2022
Public Version Number
6
DI Record Publish Date
April 01, 2020
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 69 |