Identity
- Trade Name
- LIFESOUND FDA UDI
- Generic Name
- Electronic oesophageal stethoscope, single-use FDA UDI
- Device Name
- 24FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR FDA UDI
- Model / Reference
- 10-1560-001 FDA UDI
- Description
- 24FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817499020033 FDA UDI
- FDA Product Code
- BZT FDA UDI
- GMDN Term
- Electronic oesophageal stethoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electronic oesophageal stethoscope, single-use
Lifesound by Novamed-Usa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electronic oesophageal stethoscope, single-use.
- Truer Medical, Inc. — TRUER MEDICAL, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Truer Medical, Inc. — TRUER MEDICAL, INC. · Class II
- Mon-a-Therm — Covidien LP · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novamed-Usa
Sources (1)
- FDA UDI 00051021-a667-4020-a1f2-bf50868c2c47 34 fields · synced May 31, 2026