Catalog Number

-

Brand Name

DDU-2XXX Series ECGMA Cable, IEC Configuration

Version/Model Number

DAC-2021

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121853

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Public Device Record Key

e736d6fe-57c2-46ed-9f5f-b85ff860b5e3

Public Version Date

December 10, 2018

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-