Vasomedical™Lumenair™ EECP® Therapy System V10-0020-1

GUDID 00817980020788

System, Lumenair

VASOMEDICAL, INC.

External counterpulsation system, stationary

• Primary Device ID: 00817980020788
• NIH Device Record Key: 7b68dc5e-a564-4e65-8308-d4a24da52e87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vasomedical™Lumenair™ EECP® Therapy System
• Version Model Number: Model Lumenair
• Catalog Number: V10-0020-1
• 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 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817980020788 [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™Lumenair™ EECP® Therapy System]

• 00817980020795: System, Lumenair - Reconditioned
• 00817980020788: System, Lumenair