DEVICE: i8 Diagnostic Ultrasound System (06945121406567)

Device Identifier (DI) Information

i8 Diagnostic Ultrasound System
i8
In Commercial Distribution

CHISON Medical Technologies Co., Ltd.
06945121406567
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
General-purpose ultrasound imaging system A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
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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 [?]
K140364 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

b74988f4-288a-473d-a2fd-d986c1bf99db
July 06, 2018
4
October 08, 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
06945121407083 1 06945121406567 In Commercial Distribution
06945121407076 1 06945121406567 In Commercial Distribution
06945121407069 1 06945121406567 In Commercial Distribution
06945121407052 1 06945121406567 In Commercial Distribution
06945121407045 1 06945121406567 In Commercial Distribution
06945121407038 1 06945121406567 In Commercial Distribution
06945121407021 1 06945121406567 In Commercial Distribution
06945121407014 1 06945121406567 In Commercial Distribution
06945121407007 1 06945121406567 In Commercial Distribution
06945121406994 1 06945121406567 In Commercial Distribution
06945121406871 1 06945121406567 In Commercial Distribution
06945121406888 1 06945121406567 In Commercial Distribution
06945121406895 1 06945121406567 In Commercial Distribution
06945121406901 1 06945121406567 In Commercial Distribution
06945121406918 1 06945121406567 In Commercial Distribution
06945121406925 1 06945121406567 In Commercial Distribution
06945121406932 1 06945121406567 In Commercial Distribution
06945121406949 1 06945121406567 In Commercial Distribution
06945121406956 1 06945121406567 In Commercial Distribution
06945121406963 1 06945121406567 In Commercial Distribution
06945121406970 1 06945121406567 In Commercial Distribution
06945121406987 1 06945121406567 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

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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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