Catalog Number

-

Brand Name

M SERIES

Version/Model Number

40010011000023010

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

K062537

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Public Device Record Key

4c3b660b-3b6d-4f40-b391-38e9541c958d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-