MR Patient Care Neonatal Size 4 NBP Cuffs (10) 989803183201

GUDID 10884838101392

INVIVO CORPORATION

Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable
Primary Device ID10884838101392
NIH Device Record Key8d7b113a-61d6-40ab-add2-54c4169c214c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Patient Care Neonatal Size 4 NBP Cuffs (10)
Version Model Number989803183201
Catalog Number989803183201
Company DUNS013649151
Company NameINVIVO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
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Emailxx@xx.xx
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Emailxx@xx.xx
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Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx

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
GS100884838101395 [Unit of Use]
GS110884838101392 [Primary]

FDA Product Code

DXNSystem, measurement, blood-pressure, non-invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-08
Device Publish Date2021-05-31

Devices Manufactured by INVIVO CORPORATION

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00884838115279 - Invivo2022-11-30 Kit, Enhanced Access, Bilateral Upgrade consists of Fiducial Marker Block; 3 Grid Plates Enhanced Access-Lateral; 3 Grid Plates
00884838115309 - Invivo2022-11-30 dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grids Upper dS Breast 16Ch I/T; 4 Medial Grids dS Breast 16CH I/T; MRI Needl
00884838115255 - Invivo2022-11-28 BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; M
00884838115507 - Sentinelle2022-10-24 DS Sentinelle Breast 16CH Coil Kit, 1.5T Consists of 1CH Left and Right Lateral Coils and Medial Plug with box of 10 Sentinelle
00884838115514 - Sentinelle2022-10-24 DS Sentinelle Breast coil, Biopsy Kit 3.0T Consists of 1CH Left and Right Lateral Coils and Medial Plug with box of 10 Sentinell
00884838105195 - Sentinelle2022-10-20 dS 3.0T 4CH Lateral Left
00884838105201 - Sentinelle2022-10-20 dS 3.0T 4CH Lateral Right

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