DEVICE: EBit Series Diagnostic Ultrasound System (06945121409704)

Device Identifier (DI) Information

EBit Series Diagnostic Ultrasound System
EBit 60
In Commercial Distribution

CHISON Medical Technologies Co., Ltd.
06945121409704
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
Extracorporeal ultrasound imaging transducer, hand-held A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. 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
IYO System, Imaging, Pulsed Echo, Ultrasonic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K162172 000
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Sterilization

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

[?]
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

7c6d0db0-1100-4bd3-8abf-60de7eca6a91
July 06, 2018
4
September 24, 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
06945121410663 1 06945121409704 In Commercial Distribution
06945121410656 1 06945121409704 In Commercial Distribution
06945121410649 1 06945121409704 In Commercial Distribution
06945121410632 1 06945121409704 In Commercial Distribution
06945121410625 1 06945121409704 In Commercial Distribution
06945121410618 1 06945121409704 In Commercial Distribution
06945121410601 1 06945121409704 In Commercial Distribution
06945121410595 1 06945121409704 In Commercial Distribution
06945121410465 1 06945121409704 In Commercial Distribution
06945121410458 1 06945121409704 In Commercial Distribution
06945121410441 1 06945121409704 In Commercial Distribution
06945121410434 1 06945121409704 In Commercial Distribution
06945121410427 1 06945121409704 In Commercial Distribution
06945121410410 1 06945121409704 In Commercial Distribution
06945121410403 1 06945121409704 In Commercial Distribution
06945121410397 1 06945121409704 In Commercial Distribution
06945121410380 1 06945121409704 In Commercial Distribution
06945121410373 1 06945121409704 In Commercial Distribution
06945121410366 1 06945121409704 In Commercial Distribution
06945121410359 1 06945121409704 In Commercial Distribution
06945121410472 1 06945121409704 In Commercial Distribution
06945121410489 1 06945121409704 In Commercial Distribution
06945121410496 1 06945121409704 In Commercial Distribution
06945121410502 1 06945121409704 In Commercial Distribution
06945121410519 1 06945121409704 In Commercial Distribution
06945121410526 1 06945121409704 In Commercial Distribution
06945121410533 1 06945121409704 In Commercial Distribution
06945121410540 1 06945121409704 In Commercial Distribution
06945121410557 1 06945121409704 In Commercial Distribution
06945121410564 1 06945121409704 In Commercial Distribution
06945121410571 1 06945121409704 In Commercial Distribution
06945121410588 1 06945121409704 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)

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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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