Catalog Number

-

Brand Name

DDU-1XX Pediatric Rescue Pads

Version/Model Number

DDP-200P

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K033896,K033896

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Public Device Record Key

19cd812d-4e1b-4276-bc4f-07e65a8b8b00

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

40815098020438

Quantity per Package

20

Contains DI Package

00815098020430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-