MR Patient Care Portal Remote Display # 5000 866162

GUDID 00884838091948

MR Patient Care Portal 5000

INVIVO CORPORATION

General-purpose multi-parameter bedside monitor

• Primary Device ID: 00884838091948
• NIH Device Record Key: 46fd52fa-cab3-40f5-926f-145a1c0eebf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Patient Care Portal Remote Display # 5000
• Version Model Number: MR Patient Care Portal 5000
• Catalog Number: 866162
• Company DUNS: 013649151
• Company Name: INVIVO CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 540 millibar and 1010 millibar
• Storage Environment Atmospheric Pressure: Between 405 Millimeter of Mercury and 758 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838091948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212227

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-11
• Device Publish Date: 2022-04-01

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