Duns Number:071595540
Catalog Number
2516H-PC
Brand Name
PadPro
Version/Model Number
2516H-PC
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
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
K020203,K020203
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
eff62a0a-49b1-4be9-b7ec-e77a54b2dccc
Public Version Date
February 03, 2022
Public Version Number
6
DI Record Publish Date
September 23, 2014
Package DI Number
20653405065354
Quantity per Package
10
Contains DI Package
10653405065357
Package Discontinue Date
February 02, 2022
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 |