Change Healthcare Cardiology Hemo

GUDID 17540262100020

CHANGE HEALTHCARE ISRAEL LTD

Cardiac catheterization laboratory computer

• Primary Device ID: 17540262100020
• NIH Device Record Key: a1bcae5f-6f8a-471c-bf8e-a29887b1cd48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Cardiology Hemo
• Version Model Number: 14.1.1
• 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	17540262100020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131497

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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: 2018-12-24
• Device Publish Date: 2018-11-22

On-Brand Devices [Change Healthcare Cardiology Hemo]

• 17540262100020: 14.1.1
• 17540262100013: 14.1