Duns Number:058614483
Device Description: BIS LoC 2 Channel Refurbished, Software Version 1.13 For use with Philips Patient Monitors
Catalog Number
-
Brand Name
BIS
Version/Model Number
186-0195-PHSPS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 06, 2022
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
K072286
Product Code
OLW
Product Code Name
Index-generating electroencephalograph software
Public Device Record Key
9880e793-4066-4e8a-9d8d-26cb27c5f7e2
Public Version Date
July 11, 2022
Public Version Number
5
DI Record Publish Date
August 15, 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 | 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 |