Ultraview DM3 175-6110

GUDID 00851920007019

The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.

ZOE MEDICAL INCORPORATED

Transportable physiologic monitoring system Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 00851920007019
• NIH Device Record Key: 9023afae-c2b2-488e-ae62-db51d439ecf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultraview DM3
• Version Model Number: 91330-MT
• Catalog Number: 175-6110
• Company DUNS: 848429929
• Company Name: ZOE MEDICAL INCORPORATED
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com
• Phone: 978-887-4013
• Email: customersupport@zoemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851920007019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093802

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2016-09-22

On-Brand Devices [Ultraview DM3]

• 00851920007033: The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs
• 00851920007026: The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs
• 00851920007019: The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs
• 00851920007002: The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs