MR Patient Care Short Neonatal ECG 2.0 Cable AAMI 989803152331

GUDID 00884838102347

INVIVO CORPORATION

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Primary Device ID00884838102347
NIH Device Record Key4ed4ae5f-18e8-440e-9b88-03484de57c74
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Patient Care Short Neonatal ECG 2.0 Cable AAMI
Version Model Number989803152331
Catalog Number989803152331
Company DUNS013649151
Company NameINVIVO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
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Phone+1(999)999-9999
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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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Emailxx@xx.xx
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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 TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838102347 [Primary]

FDA Product Code

DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-21
Device Publish Date2021-05-13

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00884838105195 - Sentinelle2022-10-20 dS 3.0T 4CH Lateral Left
00884838105201 - Sentinelle2022-10-20 dS 3.0T 4CH Lateral Right

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