SpO2.COM® RS-1 adult SpO2 reusable sensor

GUDID 00843997000505

MASIMO CORPORATION

Pulse oximeter probe, reusable

• Primary Device ID: 00843997000505
• NIH Device Record Key: e5656b0e-2fea-46d1-8973-d0324f744a65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2.COM® RS-1 adult SpO2 reusable sensor
• Version Model Number: 1778
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997000505 [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: 4
• Public Version Date: 2018-12-03
• Device Publish Date: 2016-08-23

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• 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