DEVICE: CBit Series Digital Color Doppler Ultrasound System (06945121413015)

Device Identifier (DI) Information

CBit Series Digital Color Doppler Ultrasound System
CBit 9
In Commercial Distribution

CHISON Medical Technologies Co., Ltd.
06945121413015
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

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
40761 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IYO System, Imaging, Pulsed Echo, Ultrasonic
IYN System, Imaging, Pulsed Doppler, Ultrasonic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K180974 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

e606fa7f-9e12-460e-adb0-46e98bec73ee
February 22, 2023
5
February 24, 2021
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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
06945121413039 1 06945121413015 In Commercial Distribution
06945121413053 1 06945121413015 In Commercial Distribution
06945121413404 1 06945121413015 In Commercial Distribution
06945121413411 1 06945121413015 In Commercial Distribution
06945121414623 1 06945121413015 In Commercial Distribution
06945121414630 1 06945121413015 In Commercial Distribution
06945121414692 1 06945121413015 In Commercial Distribution
06945121414647 1 06945121413015 In Commercial Distribution
06945121414654 1 06945121413015 In Commercial Distribution
06945121414661 1 06945121413015 In Commercial Distribution
06945121414678 1 06945121413015 In Commercial Distribution
06945121414685 1 06945121413015 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

[?]
No Customer Contact currently defined
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