Centroid 4302

GUDID 00843997012409

Centroid Patient Movement tracker

MASIMO CORPORATION

Ambulatory fall sensor

• Primary Device ID: 00843997012409
• NIH Device Record Key: f792d455-d0a3-417e-a7a0-38072a03df7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centroid
• Version Model Number: 4302
• Catalog Number: 4302
• Company DUNS: 780421038
• Company Name: MASIMO CORPORATION
• Device Count: 10
• 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: 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 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997012409 [Unit of Use]
GS1	10843997012406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191882

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

Devices Manufactured by MASIMO CORPORATION

• 00843997016896 - NomoLine: 2025-06-02 NomoLine ISA OR+
• 00843997016919 - NomoLine: 2025-06-02 NomoLine ISA AX+
• 00843997016544 - Nomoline: 2025-04-09 NomoLine ISA OR+
• 00843997017640 - Stork: 2024-11-08 Stork Hub
• 00843997017589 - Stork: 2024-11-08 Stork Sensor
• 00843997016551 - Home Health Kit: 2024-09-17 Home Health Kit
• 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