Catalog Number

-

Brand Name

DDU-1XXX/2XXX Series Pediatric Rescue Pads

Version/Model Number

DDP-2002

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)

-

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

K081259,K081259

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Public Device Record Key

19d77bb7-36d0-4eae-87f9-f1376ef8e1b4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

40815098020452

Quantity per Package

20

Contains DI Package

00815098020454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-