LNCS® Neo-L SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor

GUDID 10843997000311

MASIMO CORPORATION

Pulse oximeter probe, single-use

• Primary Device ID: 10843997000311
• NIH Device Record Key: a3167645-25b0-4cad-8663-3c8ad0b4e661
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LNCS® Neo-L SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor
• Version Model Number: 1862
• Company DUNS: 780421038
• Company Name: MASIMO CORPORATION
• Device Count: 20
• 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	00843997000314 [Unit of Use]
GS1	10843997000311 [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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• 00843997017442 - Radius PPG: 2024-09-17 Masimo SafetyNet, Radius PPG Chip
• 00843997009065 - Radius VSM: 2024-08-27 Radius VSM Multi-functional Reusable Pod, 1/Box
• 00843997009430 - Radius VSM: 2024-08-27 Radius VSM NIBP Module, 1/Box
• 00843997010337 - Radius VSM: 2024-08-27 Radius VSM Kit with Reusable Pod & NIBP
• 00843997009263 - Radius VSM: 2024-08-27 Radius VSM Kit with NIBP