Vasomedical™ AngioNew -VI EECP® Therapy System A12-0003

GUDID 00817980020764

System, AngioNew VI, 110V

VASOMEDICAL, INC.

External counterpulsation system, mobile

• Primary Device ID: 00817980020764
• NIH Device Record Key: a5a1624f-4a84-4aa5-9306-d7936b14e456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vasomedical™ AngioNew -VI EECP® Therapy System
• Version Model Number: Model AngioNew VI
• Catalog Number: A12-0003
• Company DUNS: 197210248
• Company Name: VASOMEDICAL, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(516)508-5818
• Email: eohara@vasomedical.com
• Phone: +1(516)508-5818
• Email: eohara@vasomedical.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817980020764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033617

FDA Product Code

• DRN: Device, counter-pulsating, external

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: 2016-11-29

On-Brand Devices [Vasomedical™ AngioNew -VI EECP® Therapy System]

• 00817980020771: System, AngioNew VI, 220V
• 00817980020764: System, AngioNew VI, 110V