Ultraview DM3 175-6100

GUDID 00851920007002

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

• Primary Device ID: 00851920007002
• NIH Device Record Key: 8d640a25-a4d6-40ce-bc00-d8e4883238c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultraview DM3
• Version Model Number: 91330-M
• Catalog Number: 175-6100
• 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	00851920007002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093802

FDA Product Code

• DQA: Oximeter

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