DEVICE: HITACHI (04580292773791)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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37891 | Oesophageal ultrasound imaging transducer, reusable |
An ultrasound imaging transducer assembly enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, designed to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment). Also known as an oesophageal endosonography probe or transducer, it is composed of either a single transducer element or an array of transducer elements, i.e., piezoelectric element(s), active element(s), or crystal(s), and associated damping, backing, and matching layer materials. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IYO | System, Imaging, Pulsed Echo, Ultrasonic |
ITX | Transducer, Ultrasonic, Diagnostic |
IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
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 -20 and 60 Degrees Celsius |
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 68 and 106 KiloPascal |
Handling Environment Temperature: between 15 and 40 Degrees Celsius |
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 68 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
59b8b947-495d-461e-b2d2-0d1c361235a3
July 05, 2021
4
September 13, 2016
July 05, 2021
4
September 13, 2016
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