PHILIPS HeartStart Telemedicine System 861440

GUDID 00884838040861

HeartStart Telemedicine System

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software Cardiology information system application software 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