Duns Number:058614483
Device Description: 4 Electrode Sensor For use with BIS Monitoring Systems
Catalog Number
-
Brand Name
BIS
Version/Model Number
186-0106
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
Yes
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
K093183,K093183,K093183,K093183
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
b78cb6c8-f274-4616-a48a-10bf3911b5cf
Public Version Date
October 28, 2022
Public Version Number
13
DI Record Publish Date
September 25, 2016
Package DI Number
10884521133884
Quantity per Package
2
Contains DI Package
10884521134300
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |