Catalog Number

861287

Brand Name

AC Power Module

Version/Model Number

861287

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

K062233

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Public Device Record Key

497e8b5a-5922-4ab5-96c2-16307719a431

Public Version Date

November 24, 2021

Public Version Number

2

DI Record Publish Date

May 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-