Rad-97

GUDID 00843997014212

with noninvasive blood pressure, and camera

MASIMO CORPORATION

Pulse Co-oximeter

• Primary Device ID: 00843997014212
• NIH Device Record Key: 1ade2494-68bf-4570-bb74-fdbfcb5668f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rad-97
• Version Model Number: 9798
• Company DUNS: 780421038
• Company Name: MASIMO 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: true
• 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

Customer Support Contacts

• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997013703 [Direct Marking]
GS1	00843997014212 [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: 2019-10-01
• Device Publish Date: 2019-09-23

On-Brand Devices [Rad-97]

• 00843997014281: Home Use with noninvasive blood pressure, and camera
• 00843997014229: with NomoLine Capnography, and camera
• 00843997014212: with noninvasive blood pressure, and camera
• 00843997014205: with Camera
• 00843997014199: Home Use with camera
• 00843997013864: Rad-97 with NomoLine Capnography
• 00843997013857: Rad-97 with non-invasive blood pressure
• 00843997012782: Rad-97 with NomoLine Capnography
• 00843997012775: Rad-97 with non-invasive blood pressure
• 00843997012317: Rad-97
• 00843997016612: Kit, Rad-97, NIBP, Home Use