Duns Number:058614483
Device Description: PHILIPS BILATERAL SENSOR KIT
Catalog Number
-
Brand Name
BIS
Version/Model Number
186-0212-PH
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"
-
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
K143506,K143506,K143506
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
e23aafd3-4958-47e6-94fc-cbf2beed7ec0
Public Version Date
October 14, 2022
Public Version Number
6
DI Record Publish Date
September 19, 2018
Package DI Number
90884521548387
Quantity per Package
9999
Contains DI Package
10884521548381
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 |