DeRoyal
Esophageal Stethoscope With Temperature Sensor
3manufacturers in China registered for this device type
40catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | BZT |
| Device type | Stethoscope, Esophageal, With Electrical Conductors |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1920 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2023-07-23 |
| Record revised | 2018-03-29 (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, box of 50, case of 100, case of 300 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00129-P | In distribution | |
| 81-040712 | In distribution | |
| 81-060012 | In distribution | |
| 81-040424 | In distribution | |
| M1024205VY | In distribution | |
| 81-041424 | In distribution | |
| 81-040409EU | In distribution | |
| 81-044418 | In distribution | |
| V81-050418 | In distribution | |
| 81-070018 | In distribution | |
| 81-041409 | In distribution | |
| 81-070012 | In distribution | |
| 81-051418 | In distribution | |
| 81-070009 | In distribution | |
| V81-040418 | In distribution | |
| 81-060018 | In distribution | |
| 81-050418 | In distribution | |
| 81-040718 | In distribution | |
| 81-050709 | In distribution | |
| 81-040409 | In distribution | |
| 81-050409 | In distribution | |
| 81-040418EU | In distribution | |
| M1024215VY | In distribution | |
| 81-040424EU | In distribution | |
| 81-050712 | In distribution | |
| M1024218VY | In distribution | |
| 81-040412EU | In distribution | |
| 81-050412 | In distribution | |
| 81-040724 | In distribution | |
| 81-040709 | In distribution | |
| 81-050724 | In distribution | |
| 81-041412 | In distribution | |
| 81-041418 | In distribution | |
| M1024212VY | In distribution | |
| 81-040412 | In distribution | |
| 81-050718 | In distribution | |
| 81-040418 | In distribution | |
| 81-060024 | In distribution | |
| 81-050424 | In distribution | |
| M00129-HPG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193027 | 2020-04-02 |
| K940169 | 1994-07-28 |
| K925789 | 1993-07-13 |
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.