Identity
- Trade Name
- Mon-a-Therm FDA UDI
- Generic Name
- Electronic oesophageal stethoscope, single-use FDA UDI
- Device Name
- Esophageal Stethoscope with Temperature Sensor 400TM FDA UDI
- Model / Reference
- 90043 FDA UDI
- Description
- Esophageal Stethoscope with Temperature Sensor 400TM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20884521031736 FDA UDI
- 510(k) Number
- K811862 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 24 French FDA UDI
Category: Electronic oesophageal stethoscope, single-use
Mon-a-Therm by Covidien LP — 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
- LIFESOUND — NOVAMED-USA · Class II
- NOVATEMP — NOVAMED-USA · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Cleared under the same submission
K811862 also covers:
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 |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 06db4485-b7e7-4ba4-8565-4268852fdee7 36 fields · synced May 30, 2026