Catalog Number

2059145-001

Brand Name

GE Healthcare

Version/Model Number

DF55N

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"

Yes

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

K072233,K072233,K072233

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Public Device Record Key

cf3545ff-6403-476a-854a-b237b313601c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 14, 2015

Package DI Number

39005531504609

Quantity per Package

12

Contains DI Package

29005531504602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box