DEVICE: ECO Series Diagnostic Ultrasound Systems (06945121407335)

Device Identifier (DI) Information

ECO Series Diagnostic Ultrasound Systems
ECO 3
In Commercial Distribution

CHISON Medical Technologies Co., Ltd.
06945121407335
GS1

1
544914187 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Foetal Doppler system probe A hand-operated component of a foetal Doppler system which is placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
IYN System, Imaging, Pulsed Doppler, Ultrasonic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131305 000
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

73868da8-6895-40ac-82b6-97fa3b267f8a
July 06, 2018
3
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
06945121408073 1 06945121407335 In Commercial Distribution
06945121408066 1 06945121407335 In Commercial Distribution
06945121408059 1 06945121407335 In Commercial Distribution
06945121408042 1 06945121407335 In Commercial Distribution
06945121408035 1 06945121407335 In Commercial Distribution
06945121408028 1 06945121407335 In Commercial Distribution
06945121408011 1 06945121407335 In Commercial Distribution
06945121408004 1 06945121407335 In Commercial Distribution
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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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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