740 SELECT 01-02-1007

GUDID 00851920007118

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

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 ID00851920007118
NIH Device Record Key61c48d5a-2dd3-4c63-b29c-3e00696729ee
Commercial Distribution StatusIn Commercial Distribution
Brand Name740 SELECT
Version Model Number740 SELECT-XNA00
Catalog Number01-02-1007
Company DUNS848429929
Company NameZOE MEDICAL INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com
Phone978-887-4013
Emailcustomersupport@zoemedical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851920007118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [740 SELECT]

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

Trademark Results [740 SELECT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
740 SELECT
740 SELECT
85832779 4539078 Live/Registered
CAS Medical Systems, Inc.
2013-01-25

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