DEVICE: WHALE (06970528550056)
Device Identifier (DI) Information
WHALE
P9
In Commercial Distribution
Beijing East Whale Imaging Technology Co.,Ltd.
P9
In Commercial Distribution
Beijing East Whale Imaging Technology Co.,Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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36208 | Ultrasound mobile medical facility |
A vehicle, e.g., a van, trailer, or other kind of mobile enclosure, that is equipped with at least one diagnostic ultrasound system and related instrumentation. It is typically driven or towed between various geographical locations and used as a freestanding ultrasound imaging mobile unit. It will include special mounting and stabilization components for the installed ultrasound systems and other devices, e.g., film processors, telemedicine systems, picture archiving and communication system (PACS), or camera. Power sources and other equipment necessary to ensure adequate functioning of the system(s), are included.
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FDA Product Code
[?]Product Code | Product Code Name |
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ITX | Transducer, Ultrasonic, Diagnostic |
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K160343 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 55 Degrees Celsius |
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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Width: 598 Millimeter |
Length: 524 Millimeter |
Device Record Status
fb8f7617-4900-42c2-9c4e-01987e283c2f
July 06, 2018
3
September 04, 2016
July 06, 2018
3
September 04, 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