DEVICE: Mothership Wireless Fetal Tocodynamometer Transducer, Button Style (00852189007345)
Device Identifier (DI) Information
Mothership Wireless Fetal Tocodynamometer Transducer, Button Style
F1
In Commercial Distribution
TENACORE HOLDINGS, INC.
F1
In Commercial Distribution
TENACORE HOLDINGS, INC.
Mothership Wireless Fetal Tocodynamometer Transducer, Button Style
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HGM | System, Monitoring, Perinatal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d88c1fb5-a3cb-4d0d-a2fa-c50a79fd7e2c
March 29, 2018
2
October 16, 2017
March 29, 2018
2
October 16, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined