DEVICE: I2S6 Doppler Probe (05055679400076)

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Device Identifier (DI) Information

I2S6 Doppler Probe
9090-7015

DELTEX MEDICAL LIMITED
05055679400076
GS1
1
A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the frequency of the reflected ultrasound waves caused by the moving blood cells are translated by the CardioQ™ into a real time display of the velocity of the blood against time. Analysis of the waveform provides information on a range of cardiac parameters to be derived.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Transoesophageal vascular ultrasound probe A sterile device intended to be inserted into the oesophagus, orally or nasally, to continuously measure blood flow in the descending aorta by ultrasonic Doppler technology for assessment of cardiac output and/or fluid status. It is typically constructed of flexible materials (e.g., polymers) and has a metal conducting core; it has multiple sensors at the distal end and a connector at the proximal end. It is typically used during general anaesthesia or in intensive care. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DPT Probe, Blood-Flow, Extravascular
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Sterilization

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

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Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 89 Centimeter
Depth: 50 Centimeter
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Device Status

In Commercial Distribution
September 07, 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
5055679401547 5 05055679400076 In Commercial Distribution Kraft Cardboard
5055679401714 18 5055679401547 In Commercial Distribution Kraft Cardboard
5055679401721 19 5055679401547 In Commercial Distribution Kraft Cardboard
5055679401738 20 5055679401547 In Commercial Distribution Kraft Cardboard
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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)

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

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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+4401243774837
customer.services@deltexmedical.com
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