PHILIPS HeartStart Telemedicine System 861440

GUDID 00884838040861

HeartStart Telemedicine System

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Cardiology information system application software

• Primary Device ID: 00884838040861
• NIH Device Record Key: ef08dab0-c7b9-4180-b156-614534d3a5a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHILIPS HeartStart Telemedicine System
• Version Model Number: 861440
• Catalog Number: 861440
• Company DUNS: 079503890
• Company Name: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838040861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091176

FDA Product Code

• MSX: System,Network And Communication,Physiological Monitors

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [PHILIPS HeartStart Telemedicine System]

• 00884838040878: HeartStart Telemedicine System Upgrade
• 00884838040861: HeartStart Telemedicine System