Corsano CardioWatch 287-2 System

Basic Information

• Brand Name: Corsano CardioWatch 287-2 System
• Primary DI: 08720256776529
• Version / Model: CardioWatch 287-2
• Catalog Number: CW287-2
• Company Name: Corsano Health B.V.
• Labeler DUNS: 493148003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-19
• Public Version: 1
• Public Version Date: 2024-06-27
• Public Version Status: New
• Public Device Record Key: 52c58cd8-aa80-4846-9599-0dcdde57cd95

Device Description

Corsano Health Wearable Monitoring System

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	870.2300	2
DQA	Oximeter	Cardiovascular	870.2700	2
BZG	Spirometer, Diagnostic	Anesthesiology	868.1840	2
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
FRI	Scale, Stand-On, Patient	General Hospital	880.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12391	Wearable multiple physiological parameter recorder, reusable	An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720256776529	GS1

Premarket Submissions

Submission Number	Supplement Number
K232548	000