Mon-a-Therm
Esophageal Stethoscope with Temperature Sensor 400TM
3manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Fujian (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Inventech Xiamen Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
| Starboard Medical (Jiangsu) Co., Ltd. | Sheyang | Jiangsu | Contract manufacturer | 2 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | BZT |
| Device type | Stethoscope, Esophageal, With Electrical Conductors |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1920 |
| 510(k) | K251025 |
| Record published | 2016-09-24 |
| Record revised | 2026-07-16 (version 10) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not expose to UV |
| Packaging | Case of 2, pack_or_inner_pack of 25 |
| Sizes | Catheter gauge 9 to 24 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90041 | Catheter Gauge: 12 French; | In distribution |
| 90049 | Catheter Gauge 9 Fr | In distribution |
| 90041 | Catheter Gauge 12 Fr | In distribution |
| 90042 | Catheter Gauge 18 Fr | In distribution |
| 90042 | Catheter Gauge: 18 French; | In distribution |
| 90049 | Catheter Gauge 9 Fr | In distribution |
| 90043 | Catheter Gauge 24 Fr | In distribution |
| 90043 | Catheter Gauge 24 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 40 |
| Level 1 | ICU Medical, Inc | 16 |
| sourcemark | Sourcemark, LLC. | 15 |
| Truer Medical, Inc. | Truer Medical, Inc. | 11 |
| Novatemp | Novamed-USA | 10 |
| Lifesound | Novamed-USA | 9 |
| Starboard Temperature Probes | Starboard Medical, Inc. | 6 |
| Medline | Medline Industries, Inc. | 6 |
| Temperature Probes | Philips Medical Systems Hsg | 3 |
| Tapscope | Cardiocommand, Inc. | 2 |
| Curaplex | Bound Tree Medical, LLC | 1 |
| EC-View | Cardiocommand, Inc. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2026-04-23 | Class II | Under Investigation by firm | Temperature probe devices lack FDA clearance. | 23,000 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.