Catalog Number

-

Brand Name

PHILIPS HeartStart FR3 Rigid Case

Version/Model Number

989803149971

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

-

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Public Device Record Key

d1400b88-eaf4-45b9-8eaa-2bdea533595e

Public Version Date

December 07, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-