Heroic Faith

Basic Information

• Brand Name: Heroic Faith
• Primary DI: 04719882170119
• Version / Model: Airmod
• Company Name: Heroic Faith International Ltd.
• Labeler DUNS: 657647550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-22
• Public Version: 1
• Public Version Date: 2026-04-30
• Public Version Status: New
• Public Device Record Key: 35150e52-886b-4452-81d0-3ee0fafcdaa5

Device Description

Airmod is an Android-based software application designed to aid healthcare professionals by monitoring a patient’s breathing in real time. It can detect inhalation acoustics and provides respiratory rates based on the analysis of the acoustic signals of breathing sounds collected by AccurSound Electronic Stethoscope AS-101. Airmod is intended for the continuous monitoring of respiratory rate (RR) in adults who are subjected to procedural sedation in which the depth of sedation ranges from moderate and deep sedation/anesthesia to general anesthesia and the consciousness status of patients ranges from clear to unarousable. Airmod is designed for use in hospitals and healthcare facilities performing procedural sedation/anesthesia.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35194	Respiratory apnoea monitoring system	An assembly of devices designed to detect the cessation of breathing (apnoea) in infants and adults who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s). It alarms primarily upon the cessation of breathing timed from the last detected breath, and may also include indirect methods of apnoea detection such as monitoring of heart rate and other physiological parameters associated with respiration. It may print-out this data. It will typically include a mains electricity (AC-powered) monitoring unit with software, patient leads, and possibly a recorder to record, display, or print data on a patient's breathing condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719882170119	GS1

Premarket Submissions

Submission Number	Supplement Number
K242798	000