Duns Number:961027315
Device Description: KendallH34LG Foam Monitoring electrode with Liquid gel 50x45mm
Catalog Number
31.1345.21
Brand Name
Kendall
Version/Model Number
31.1345.21
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
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
cb55475e-238c-45f1-a4b8-ddbedbf5153e
Public Version Date
April 21, 2022
Public Version Number
1
DI Record Publish Date
April 13, 2022
Package DI Number
30192253016868
Quantity per Package
10
Contains DI Package
20192253016861
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |