Sourcemark
18 French Esophageal Stethoscope with 400 Series Thermistor Temperature Sensor- Sterile
3manufacturers in China registered for this device type
15catalogue 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 | Sourcemark, LLC. |
|---|---|
| FDA product code | BZT |
| Device type | Stethoscope, Esophageal, With Electrical Conductors |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1920 |
| 510(k) | K111050 |
| Record published | 2019-02-19 |
| Record revised | 2020-07-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 50, case of 35, case of 30, box of 100, case of 200 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM9400ER | In distribution | |
| SM4503NP | In distribution | |
| SM4504NP | In distribution | |
| SM12400ER | In distribution | |
| SM18400ES | In distribution | |
| SM4506NP | In distribution | |
| SM4501NP | In distribution | |
| SM9400ES | In distribution | |
| SM24400ES | In distribution | |
| SM12400ES | In distribution | |
| SM4507NP | In distribution | |
| SM4505NP | In distribution | |
| SM12400ES | In distribution | |
| SM4220 | In distribution | |
| SM4200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 40 |
| Level 1 | ICU Medical, Inc | 16 |
| Truer Medical, Inc. | Truer Medical, Inc. | 11 |
| Novatemp | Novamed-USA | 10 |
| Lifesound | Novamed-USA | 9 |
| Mon-a-Therm | Covidien LP | 8 |
| 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 |
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.