Rego Safe Mobility App

Basic Information

• Brand Name: Rego Safe Mobility App
• Primary DI: 00840828192095
• Version / Model: Rego Safe Mobility App
• Company Name: CURBELL MEDICAL PRODUCTS, INC.
• Labeler DUNS: 796452311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-23
• Public Version: 1
• Public Version Date: 2024-05-31
• Public Version Status: New
• Public Device Record Key: 1df284b9-d3e2-4238-942e-4fe9deb7662e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
KMI	Monitor, Bed Patient	General Hospital	880.2400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63286	Inpatient motion surveillance software	A software program designed to be used in a healthcare setting to track the movements of an inpatient, typically a patient in a hospital side/isolation room or nursing home, to detect high-risk behaviour (e.g., bedridden patient bed vacation attempt, fall risk) and automatically send alert notifications to healthcare staff via a central monitoring station or nurse call system in response. It is used in conjunction with video surveillance motion sensors/cameras and is intended to analyse patient motion with respect to predetermined motion threshold references.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840828192095	GS1

Customer Contacts

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