Vista Mini-CPX Silver Edition 17670

GUDID 00850440070770

Vista Interface System

Vacumed

Cardiopulmonary stress exercise monitoring system

• Primary Device ID: 00850440070770
• NIH Device Record Key: 3b3009ba-2354-4d36-8c02-139e7ae405f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vista Mini-CPX Silver Edition
• Version Model Number: 17670
• Catalog Number: 17670
• 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(800)235-3333
• Email: info@vacumed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850440070770 [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: 4
• Public Version Date: 2018-08-01
• Device Publish Date: 2016-09-14

On-Brand Devices [Vista Mini-CPX Silver Edition]

• 00850440070770: Vista Interface System
• 00850644007077: Vista Interface System