Xper Flex Cardio Physiomonitoring System 453564669081

GUDID 00884838091474

INVIVO CORPORATION

Multiple-patient intensive/general healthcare physiologic monitoring system
Primary Device ID00884838091474
NIH Device Record Key58a44d37-26d5-4bec-89e5-6ffc7e660a57
Commercial Distribution StatusIn Commercial Distribution
Brand NameXper Flex Cardio Physiomonitoring System
Version Model Number453564669081
Catalog Number453564669081
Company DUNS013649151
Company NameINVIVO CORPORATION
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
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Emailxx@xx.xx
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Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 103 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838091474 [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 Date2020-02-06
Device Publish Date2018-06-01

On-Brand Devices [Xper Flex Cardio Physiomonitoring System]

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00884838091498453564674581

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