Cardiologs Platform

GUDID G637CEA0

PHILIPS FRANCE COMMERCIAL

Cardiopulmonary physiological parameter analysis software

• Primary Device ID: G637CEA0
• NIH Device Record Key: adcdb19c-35b9-48f0-a31b-3ecb1bccff7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiologs Platform
• Version Model Number: 2.4.x
• Company DUNS: 280036084
• Company Name: PHILIPS FRANCE COMMERCIAL
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G637CEA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212112

FDA Product Code

• DPS: Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-23
• Device Publish Date: 2024-09-23