DEVICE: AcuNav 10F Ultrasound Catheter (04056869001012)

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Device Identifier (DI) Information

AcuNav 10F Ultrasound Catheter
08255790

SIEMENS MEDICAL SOLUTIONS USA, INC.
04056869001012
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ultrasound imaging cardiac catheter, steerable, single-use A sterile, steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and/or intraluminal visualization to assess cardiac anatomy and physiology, as well as visualization of other devices in the heart. It is introduced percutaneously with the distal tip actuated by the operator using controls at the proximal end to accommodate manoeuvring in the cardiac anatomy. It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
OBJ Catheter, ultrasound, intravascular
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 10 French
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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+1(800)888-7436
XX@XX.XX
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