Expression MR400 MRI Patient Monitoring System (Model MR400) 866428

GUDID 00884838056312

INVIVO CORPORATION

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 00884838056312
• NIH Device Record Key: cd8071f7-72cb-4f2a-816b-e91e8ffd3b5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Expression MR400 MRI Patient Monitoring System (Model MR400)
• Version Model Number: 866428
• Catalog Number: 866428
• Company DUNS: 013649151
• Company Name: INVIVO CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
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Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 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 Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838056312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152330

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: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-08-30

On-Brand Devices [Expression MR400 MRI Patient Monitoring System (Model MR400)]

• 00884838039131: 866185
• 00884838056312: 866428