Centroid

Basic Information

• Brand Name: Centroid
• Primary DI: 10843997012406
• Version / Model: 4302
• Catalog Number: 4302
• Company Name: MASIMO CORPORATION
• Labeler DUNS: 780421038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-08-22
• Public Version: 1
• Public Version Date: 2023-08-30
• Public Version Status: New
• Public Device Record Key: f792d455-d0a3-417e-a7a0-38072a03df7f

Device Description

Centroid Patient Movement tracker

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36693	Ambulatory fall sensor	A battery-powered electronic device intended to be worn on a patient’s body (e.g., in the form of a patch, pendant, wristband) to provide an alert signal for help when automatically activated in response to an event requiring need for assistance or care, typically in cases of falls or epileptic seizures. It consists of a sensor with a wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., phone, pager) to notify a medical professional, caregiver, neighbour, or emergency medical services (EMS) that urgent assistance is needed. It is intended to be used in the home and healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00843997012409	GS1
Primary	10843997012406	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K191882	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius