Catalog Number

-

Brand Name

Charger

Version/Model Number

1211-000100-66

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

K122839

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Public Device Record Key

119c8fdf-1ca5-4d68-8bc9-bf1995bdc1c6

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

June 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-