Sedline

GUDID 00843997012898

Sedline Module

MASIMO CORPORATION

Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic Patient monitoring system module, electroencephalographic

• Primary Device ID: 00843997012898
• NIH Device Record Key: 5163d827-ee7d-4ba1-b488-7e6128296864
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sedline
• Version Model Number: 9829
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997012898 [Primary]

FDA Product Code

• OMC: Reduced- montage standard electroencephalograph

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: 2020-09-11
• Device Publish Date: 2020-09-03

On-Brand Devices [Sedline]

• 00843997012898: Sedline Module
• 00843997013895: SedLine Module
• 00843997013475: SedLine Module