Duns Number:961027315
Device Description: H69P Repositionable Cloth electrode, small Square shape
Catalog Number
ES40281-
Brand Name
Kendall
Version/Model Number
ES40281
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
9ced9876-33d7-4641-a5f8-c73804c00e0e
Public Version Date
December 01, 2020
Public Version Number
1
DI Record Publish Date
November 23, 2020
Package DI Number
50192253017913
Quantity per Package
15
Contains DI Package
20192253017912
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 |