Duns Number:071595540
Device Description: Multifunction Electrode Cable
Catalog Number
1105
Brand Name
PadPro
Version/Model Number
1105
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 02, 2022
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
-
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
K003548
Product Code
MKJ
Product Code Name
Automated external defibrillators (non-wearable)
Public Device Record Key
bd057a95-1283-45c1-a466-aa39361de827
Public Version Date
February 04, 2022
Public Version Number
4
DI Record Publish Date
October 07, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |