Masimo Sensor

GUDID 00843997016797

Masimo Sensor Replacement

MASIMO CORPORATION

Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter

• Primary Device ID: 00843997016797
• NIH Device Record Key: b58f9a99-5d50-4dbf-a0ce-5ef04b5ae7eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Masimo Sensor
• Version Model Number: 4935
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997016797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183697

FDA Product Code

• MWI: Monitor, physiological, patient (without arrhythmia detection or alarms)

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: 2021-10-18
• Device Publish Date: 2021-10-08

Devices Manufactured by MASIMO CORPORATION

• 00843997017688 - Nomoline: 2024-03-27 NomoLine LH Bypass Tubing, 3m
• 00843997005364 - Masimo W1: 2024-03-11 Masimo W1, Tele-Health, Global
• 00843997017480 - Masimo W1: 2024-03-11 Masimo W1, Global, France
• 00843997017497 - Masimo W1: 2024-03-11 Masimo W1, Global, German
• 00843997017503 - Masimo W1: 2024-03-11 Masimo W1, Global, Switzerland
• 00843997017510 - Masimo W1: 2024-03-11 Masimo W1, Global, Italy
• 00843997017527 - Masimo W1: 2024-03-11 Masimo W1, Global, Sweden
• 00843997017534 - Masimo W1: 2024-03-11 Masimo W1, Global, Netherlands