O3

GUDID 00843997013468

O3 Regional Oximeter, Philips

MASIMO CORPORATION

Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter

• Primary Device ID: 00843997013468
• NIH Device Record Key: a2ed70e9-efb0-4995-aa5c-c12de033b339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O3
• Version Model Number: 4431
• 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: false
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997013468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182429

FDA Product Code

• MUD: Oximeter, tissue saturation

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: 2020-09-11
• Device Publish Date: 2020-09-03

On-Brand Devices [O3]

• 10843997012574: O3 Padiatric Sensor Training Kit
• 10843997011768: O2 Sensor Training Kit
• 00843997010801: O3 Sensor Pediatric Adhesive Sensor
• 00843997013499: O3 Sensor Infant/Neonatal Adhesive Sensor
• 00843997013468: O3 Regional Oximeter, Philips
• 00843997014557: O3 Infant/Neonatal Sensor Training Kit
• 00843997013888: O3 Regional Oximeter