FDA UDI
In Commercial Distribution
🇺🇸 United States
Mothership Wireless Transducers, Loop Style
DI: 00852189007383
·
Model: F1
·
TENACORE HOLDINGS, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mothership Wireless Transducers, Loop Style
- Primary DI
- 00852189007383
- Version / Model
- F1
- Company Name
- TENACORE HOLDINGS, INC.
- Labeler DUNS
- 138781799
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 0e0ab431-c6b4-44e9-81b6-38ec3e2ca0b1
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38480 | Cardiotocography telemetric monitoring system receiver | A mains electricity (AC-powered) component of a cardiotocography telemetric monitoring system designed to wirelessly receive, consolidate, and display foetal heart rate and uterine contraction signals from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor). | No | Obsolete |
| 38481 | Cardiotocography telemetric monitoring system transmitter | A body-worn, battery-powered component of a cardiotocography telemetric monitoring system designed to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals to the system's receiver. The transmitter typically includes an antenna and attached sensors (e.g., lead wires and electrodes) that are connected to the patient. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852189007383 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 131 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit