PHILIPS HeartStart Telemedicine System - HeartStart Telemedicine System Upgrade - PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Duns Number:079503890

Device Description: HeartStart Telemedicine System Upgrade

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More Product Details

Catalog Number

861441

Brand Name

PHILIPS HeartStart Telemedicine System

Version/Model Number

861441

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MSX

Product Code Name

System,Network And Communication,Physiological Monitors

Device Record Status

Public Device Record Key

ab4445e8-3ac9-4b15-ba36-e1a873fe6127

Public Version Date

December 07, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS ELECTRONICS NORTH AMERICA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14
3 A medical device with high risk that requires premarket approval 53