SpO2.COM® adult SpO2 disposable sensor

GUDID 10843997000465

MASIMO CORPORATION

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• Primary Device ID: 10843997000465
• NIH Device Record Key: fbce8397-e0d2-46c4-9640-6e3a2a5b324c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2.COM® adult SpO2 disposable sensor
• Version Model Number: 1774
• Company DUNS: 780421038
• Company Name: MASIMO CORPORATION
• Device Count: 24
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997000468 [Unit of Use]
GS1	10843997000465 [Primary]

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

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• 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