Identity
- Trade Name
- HemoTag FDA UDI
- Generic Name
- Phonocardiograph FDA UDI
- Device Name
- The HEMOTAG Device attaches to a patient's chest using standard electrodes, for 30 second, and picks up vibrational signals from the Heart. FDA UDI
- Model / Reference
- HT-101 FDA UDI
- Description
- The HEMOTAG Device attaches to a patient's chest using standard electrodes, for 30 second, and picks up vibrational signals from the Heart. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B596HT101Y2 FDA UDI
- FDA Product Code
- DQC FDA UDI
- GMDN Term
- Phonocardiograph FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.2390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Phonocardiograph
HemoTag by Aventusoft L.L.C. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Phonocardiograph.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aventusoft L.L.C.
Sources (1)
- FDA UDI f61fc945-022d-4a9a-8a18-225fd9fb0853 34 fields · synced May 30, 2026