Duns Number:961027315
Device Description: Kendall H92SG ,Foam monitoring electrode - Oval shape 57x34mm
Catalog Number
31.1925.21
Brand Name
Kendall
Version/Model Number
31.1925.21
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
3558f8f0-22e3-41b0-9e5b-0a2450fd9640
Public Version Date
March 16, 2022
Public Version Number
1
DI Record Publish Date
March 08, 2022
Package DI Number
50192253016985
Quantity per Package
12
Contains DI Package
30192253016981
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 |