740 SELECT 01-02-1025

GUDID 00851920007446

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.

ZOE MEDICAL INCORPORATED

Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 00851920007446
• NIH Device Record Key: c5e055b1-f38c-4d23-b576-4464583de978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 740 SELECT
• Version Model Number: 740 SELECT-0N0E0
• Catalog Number: 01-02-1025
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851920007446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150620

FDA Product Code

• MWI: Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-05
• Device Publish Date: 2022-09-27

On-Brand Devices [740 SELECT]

• 00851920007293: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007248: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007231: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007156: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007149: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007132: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007125: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007118: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007101: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007095: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007088: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007071: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007064: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007057: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007385: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007392: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007422: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007415: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007408: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on
• 00851920007446: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on