SpO2.COM™ SpO2 disposable sensor sample pack

GUDID 10843997010358

MASIMO CORPORATION

Pulse oximeter probe, single-use

• Primary Device ID: 10843997010358
• NIH Device Record Key: 91ed1cee-4b78-4f08-a72b-0327353a6cef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2.COM™ SpO2 disposable sensor sample pack
• Version Model Number: 1851
• 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: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10843997010358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033298

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-11-10
• Device Publish Date: 2016-08-23

Devices Manufactured by MASIMO CORPORATION

• 10843997001448 - rainbow® R20 SpCO® SpO2 SpMet® Pediatric Pulse CO-Oximeter® Adhesive Sensor: 2025-12-22 rainbow R20 SpCO SpO2 SpMet Pediatric Pulse CO-Oximeter Adhesive Sensor
• 10843997001455 - rainbow®R20L SpCO® SpO2 SpMet® Infant Pulse CO-Oximeter® Adhesive Sensor: 2025-12-22 rainbowR20L SpCO SpO2 SpMet Infant Pulse CO-Oximeter® Adhesive Sensor
• 10843997001462 - MasimoSET® rainbow R25 SpCO SpO2 SpMet® Adult Pulse CO-Oximeter® Adhesive Sensor: 2025-12-22 MasimoSET rainbow R25 SpCO SpO2 SpMet Adult Pulse CO-Oximeter Adhesive Sensor
• 10843997001479 - rainbow R25-L SpCO SpO2 SpMet® Adult/Neonatal Pulse CO-Oximeter® Adhesive Sensor: 2025-12-22 rainbow R25-L SpCO SpO2 SpMet Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor
• 10843997002322 - rainbow R1 25L SpHb SpO2 SpMet Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor: 2025-12-22 rainbow R1 25L SpHb SpO2 SpMet Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor
• 10843997002339 - R1 25 SpHb® SpO2, SpMet® Adult Pulse Co-Oximeter® Adhesive Sensor: 2025-12-22
• 10843997002346 - R1 20 Pediatric/Slender digit Pulse Co-Oximeter® Adhesive Sensor: 2025-12-22
• 10843997002353 - rainbow® R1 20L SpHb® SpO2 SpMet® Infant CO-Oximeter® Adhesive Sensor: 2025-12-22 rainbow R1 20L SpHb SpO2 SpMet Infant CO-Oximeter Adhesive Sensor