Vista-MX (Gold Edition) 17593

GUDID 00850644007046

Vista Interface System

Vacumed

Cardiopulmonary stress exercise monitoring system

• Primary Device ID: 00850644007046
• NIH Device Record Key: a104ead9-8edd-48ed-90da-874bf8d409ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vista-MX (Gold Edition)
• Version Model Number: 17593
• Catalog Number: 17593
• Company DUNS: 077967081
• Company Name: Vacumed
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(805)235-3333
• Email: info@vacumed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850644007046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864852

FDA Product Code

• BZL: COMPUTER, OXYGEN-UPTAKE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-15
• Device Publish Date: 2016-09-14

On-Brand Devices [Vista-MX (Gold Edition)]

• 00850644070460: Vista Interface System
• 00850644007046: Vista Interface System