DEVICE: DOPPLEX (05051968020161)

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Device Record History
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Device Identifier (DI) Information
DOPPLEX
IOP8-USA
In Commercial Distribution
IOP8-USA
HUNTLEIGH HEALTHCARE LIMITED
05051968020161
GS1

1
217207083 *Terms of Use
INTRAOPERATIVE PROBE 8MHZ - USA
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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?
61226 Invasive vascular ultrasound system probe
A hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ITX Transducer, Ultrasonic, Diagnostic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K032315 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between 860 and 1060 millibar
Handling Environment Atmospheric Pressure: between 860 and 1060 millibar
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Handling Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
a296488f-3a99-4c05-aafb-9a17f29e8cef
April 07, 2021
4
August 22, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4402920485885
sales@huntleigh-diagnostics.co.uk
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