Novatemp
18FR Esophageal Stethoscope With 400 Series Thermistor Sterile - 1 Each
3manufacturers in China registered for this device type
10catalogue 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 | Novamed-USA, United States |
|---|---|
| FDA product code | BZT |
| Device type | Stethoscope, Esophageal, With Electrical Conductors |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1920 |
| Establishment | Complaint-file establishment |
| Record published | 2023-06-27 |
| Record revised | 2021-03-15 (version 4) |
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 |
| Storage | Handling environment temperature 68 to 77 °F |
| Packaging | Pack of 4, pack of 20, pack of 40, case of 4, box of 40 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-1615-001 | In distribution | |
| 5-15610-001 | In distribution | |
| 10-1620-001 | In distribution | |
| 5-13218-001 | In distribution | |
| 10-1620-001 | In distribution | |
| 10-1610-001 | In distribution | |
| 5-13224-001 | In distribution | |
| 10-1615-001 | In distribution | |
| 10-1610-001 | In distribution | |
| 5-13212-001 | 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 |
| 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.