Duns Number:961027315
Device Description: Medi-Trace Cadence Adult, Defibrillation electrode -RTS (10 PR/PK) - ZOLL
Catalog Number
22770R-
Brand Name
Medi-Trace Cadence
Version/Model Number
22770R
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
MKJ
Product Code Name
Automated external defibrillators (non-wearable)
Public Device Record Key
4385cb74-7eb5-4b77-a5a3-ade749723c23
Public Version Date
August 20, 2021
Public Version Number
2
DI Record Publish Date
July 29, 2021
Package DI Number
50192253018880
Quantity per Package
10
Contains DI Package
20192253018889
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 |