Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Loop-Style, F1 Mothership Wireless Tocodynamometer Transducer, Loop…
Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Loop-Style, F1 Mothership Wireless Tocodynamometer Transducer, Loop Style, and F1 Mothership Wireless Fetal Transducer Base Station.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Mothership Wireless Transducers, Loop Style | Listed by | Tenacore LLC, United States |
| FDA product code | HGM |
| Device type | System, Monitoring, Perinatal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2740 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2017-10-16 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
| Storage | Storage environment temperature 14 to 131 °F; Storage environment humidity 0 to 95 % RH; Handling environment humidity 10 to 95 % RH; Handling environment temperature 50 to 104 °F |
| UDI direct marking | Exempt |
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.