MR Patient Care Pediatric SpO2 Grips (20) 989803166561

GUDID 10884838100999

INVIVO CORPORATION

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• Primary Device ID: 10884838100999
• NIH Device Record Key: f9ce9c40-e247-4f06-aeec-343d07eef319
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Patient Care Pediatric SpO2 Grips (20)
• Version Model Number: 989803166561
• Catalog Number: 989803166561
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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	00884838100992 [Unit of Use]
GS1	10884838100999 [Primary]

FDA Product Code

• DQA: Oximeter

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: 2021-05-11
• Device Publish Date: 2021-05-03

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• 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