Catalog Number

1200

Brand Name

PadPro

Version/Model Number

1200

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

58644a39-bebc-4889-bf15-dfa1250fb737

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

-