Heroic Faith

Primary DI
04719882170119
Brand
Heroic Faith
Company
Heroic Faith International Ltd.
Model
Airmod
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.
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242798000AirmodHeroic Faith International , Ltd.2025-02-28BZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719882170119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719882170119047198821701194719882170119

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory apnoea monitoring systemAn 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.

Regulatory Flags#

DUNS number
657647550
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719882170041Heroic FaithAS-P01V42023-09-18
04719882170065Heroic FaithAS101M2AS1012023-09-18
04719882170034Heroic FaithAS1012023-09-01

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