RD Sedline 4329

GUDID 00843997012805

RD Sedline EEG Sensor Pediatric

MASIMO CORPORATION

Analytical scalp electrode, single-use

• Primary Device ID: 00843997012805
• NIH Device Record Key: a99bd0fb-cd76-4cdd-83c7-a086c714b15f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RD Sedline
• Version Model Number: 4329
• Catalog Number: 4329
• Company DUNS: 780421038
• Company Name: MASIMO CORPORATION
• Device Count: 25
• 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
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997012805 [Unit of Use]
GS1	10843997012802 [Primary]

FDA Product Code

• OLW: Index-Generating Electroencephalograph Software

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: 2023-08-30
• Device Publish Date: 2023-08-22

On-Brand Devices [RD Sedline]

• 10843997011775: EEG Sensor Adult
• 00843997012485: RD Sedline Patient Cable
• 00843997000581: RD SedLine EEG Sensor, Pediatric
• 00843997012805: RD Sedline EEG Sensor Pediatric