Expression MR200 MRI Patient Monitor System 866120

GUDID 00884838033764

INVIVO CORPORATION

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00884838033764
• NIH Device Record Key: 459a497f-3963-46f8-9978-d2a0fca1987f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Expression MR200 MRI Patient Monitor System
• Version Model Number: 866120
• Catalog Number: 866120
• Company DUNS: 013649151
• Company Name: INVIVO CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838033764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131382

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-29

Devices Manufactured by INVIVO CORPORATION

• 00884838103740 - Sentinelle: 2023-03-06 Sentinelle, Biopsy Grid
• 00884838115279 - Invivo: 2022-11-30 Kit, Enhanced Access, Bilateral Upgrade consists of Fiducial Marker Block; 3 Grid Plates Enhanced Access-Lateral; 3 Grid Plates
• 00884838115309 - Invivo: 2022-11-30 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 - Invivo: 2022-11-28 BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; M
• 00884838115507 - Sentinelle: 2022-10-24 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 - Sentinelle: 2022-10-24 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 - Sentinelle: 2022-10-20 dS 3.0T 4CH Lateral Left
• 00884838105201 - Sentinelle: 2022-10-20 dS 3.0T 4CH Lateral Right