Duns Number:071595540
Catalog Number
2603R
Brand Name
PadPro
Version/Model Number
2603R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2020
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
K020288,K020288
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
217f21f2-e259-4f18-925b-5f8a72a9ed43
Public Version Date
September 24, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2014
Package DI Number
20653405064241
Quantity per Package
10
Contains DI Package
10653405064244
Package Discontinue Date
September 24, 2020
Package Status
Not 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 | 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 |