DEVICE: Bovie (10607151011670)
Device Identifier (DI) Information
Bovie
A3
In Commercial Distribution
A3
BOVIE MEDICAL CORPORATION
A3
In Commercial Distribution
A3
BOVIE MEDICAL CORPORATION
ACUDOP II 3MHZ OB PROBE (ONLY)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
41917 | Foetal Doppler system probe |
A hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXE | Doppler, Fetal, Ultrasound |
ITX | Transducer, Ultrasonic, Diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K090465 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 50 Degrees Celsius |
Handling Environment Humidity: between 5 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
735c0393-fd47-451c-b17e-0293eaf1fb5e
November 28, 2022
4
March 30, 2017
November 28, 2022
4
March 30, 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 |
---|---|---|---|---|---|
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