HemoTag

Primary DI
B596HT101Y2
Brand
HemoTag
Company
Aventusoft L.L.C.
Model
HT-101
Device description
The HEMOTAG Device attaches to a patient's chest using standard electrodes, for 30 second, and picks up vibrational signals from the Heart.
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQCPhonocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQCPhonocardiographCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B596HT101Y2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
PhonocardiographA device for recording heart sounds at the body surface through the heart's actions which cause vibrations that are transmitted through organs and tissue to the body surface. These are detected by microphones, processed in an electroacoustic transducer, and give sound characteristics in a phonocardiogram. This is used to assess the low frequency sounds (atrial and ventricular gallops), and high frequency sounds (mitral regurgitation and ventricular septal defect). Some also record subsonic frequencies (a few Hertz) considered as vibrations, typically recorded by an apexcardiograph. This method may also be integrated in other electrocardiograph (ECG) devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5612344040gary@aventusoft.com

Regulatory Flags#

DUNS number
004458871
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

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