FDA.reportPublic FDA data

Heroic Faith

Primary DI
04719882170034
Brand
Heroic Faith
Company
Heroic Faith International Ltd.
Model
AS101
Device description
The AS-101 is an electronic stethoscope intended for the detection and amplification of sounds associated with the heart,lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. Thedevice is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQDStethoscope, Electronic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQDStethoscope, ElectronicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719882170034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719882170034047198821700344719882170034

GMDN Terms#

Term, Definition table
TermDefinition
Electronic stethoscopeAn external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or display.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+886226590291service@heroic-faith.com

Regulatory Flags#

DUNS number
657647550
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719882170119Heroic FaithAirmod2026-04-22
04719882170041Heroic FaithAS-P01V42023-09-18
04719882170065Heroic FaithAS101M2AS1012023-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973660370001MinttiSuzhou Melodicare Medical Technology Co., Ltd.DQD2026-10-10
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DQD2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DQD2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DQD2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DQD2026-10-01
00810209880217CORE 300™ Digital Stethoscope - BlackEko Health, Inc.DQD2026-10-01
00810209880224CORE 300™ Digital Stethoscope - BerryEko Health, Inc.DQD2026-10-01
00810209880231CORE 300™ Digital Stethoscope - SunsetEko Health, Inc.DQD2026-10-01
00810209880248CORE 300™ Digital Stethoscope - PacificEko Health, Inc.DQD2026-10-01
00810209880255CORE 300™ Digital Stethoscope - CloudEko Health, Inc.DQD2026-10-01
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-06-22
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DQD2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DQD2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DQD2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DQD2026-06-12
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DQD2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DQD2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-05-18
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Health, Inc.DQD2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Health, Inc.DQD2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceEko Health, Inc.DQD2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceEko Health, Inc.DQD2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGEko Health, Inc.DQD2026-04-03
00860011561736Stethophone ProSparrow Acoustics Inc.DQD2026-02-18
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Health, Inc.DQD2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Health, Inc.DQD2026-01-29
08809427311032SkeeperSmartsound CorportationDQD2026-01-12
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceEko Health, Inc.DQD2025-11-07