Change Healthcare Cardiology ECG Management

GUDID 17540262110012

CHANGE HEALTHCARE ISRAEL LTD

Cardiac mapping system computer Cardiac mapping system computer

• Primary Device ID: 17540262110012
• NIH Device Record Key: 5b2bfe12-f7cd-4c6f-afe0-bf09a2aa6644
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Cardiology ECG Management
• Version Model Number: 14.1
• Company DUNS: 600748180
• Company Name: CHANGE HEALTHCARE ISRAEL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17540262110012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113515

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-20
• Device Publish Date: 2018-08-20

On-Brand Devices [Change Healthcare Cardiology ECG Management]

• 17540262110029: 14.1.1
• 17540262110012: 14.1