AccessGUDID - DEVICE: HemoTag (B596HT101Y2)

GUDID

Device Identifier (DI) Information

Brand Name: HemoTag
Version or Model: HT-101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aventusoft L.L.C.

Primary DI Number: B596HT101Y2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004458871 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13017	Phonocardiograph	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DQC	Phonocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f61fc945-022d-4a9a-8a18-225fd9fb0853
Public Version Date: February 06, 2024
Public Version Number: 1
DI Record Publish Date: January 29, 2024