Catalog Number

11141-000156

Brand Name

NA

Version/Model Number

11141

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P160026

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Public Device Record Key

d27e9320-f40a-43a4-8006-c32dcf836429

Public Version Date

December 03, 2020

Public Version Number

4

DI Record Publish Date

November 10, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-