Duns Number:961027315
Device Description: Kendall 500 series Diaphoretic Foam Monitoring electrode - Tear drop shape ( 30/PK)
Catalog Number
31013926-
Brand Name
Kendall
Version/Model Number
31013926
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
-
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
3477c964-7a3b-4fbb-8dda-067336c6a95c
Public Version Date
November 25, 2020
Public Version Number
1
DI Record Publish Date
November 17, 2020
Package DI Number
50192253017197
Quantity per Package
20
Contains DI Package
20192253017196
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |