The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgical setting for monitoring temperature, as well as, heart and lung sounds of anesthetized…
The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgical setting for monitoring temperature, as well as, heart and lung sounds of anesthetized patients. Inserted in the esophagus, the stethoscope provides an accurate measurement of core body temperature, as well as, transmitting clear heart and lung sounds to the anesthesiologist.
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.
Record
Regulatory record for Truer Medical, Inc. | Listed by | Truer Medical, 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, Repacker / relabeller, Manufacturer |
| 510(k) | K092716 |
| Record published | 2016-06-06 |
| Record revised | 2018-12-05 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 6, carton of 5, carton of 2, carton of 25 |
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.