Duns Number:961027315
Device Description: Medi-Trace Cadence Paediatric Defibrillation electrode (5 PR/PK) - Physio-Control
Catalog Number
22550P-
Brand Name
Medi-Trace Cadence
Version/Model Number
22550P
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
69e0e1e0-90cc-4aa8-a950-4ee792bd05b2
Public Version Date
August 27, 2021
Public Version Number
1
DI Record Publish Date
August 19, 2021
Package DI Number
50192253017555
Quantity per Package
5
Contains DI Package
20192253017554
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 |