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.
CBit 9
In Commercial Distribution
CHISON Medical Technologies Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K180974 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e606fa7f-9e12-460e-adb0-46e98bec73ee
February 22, 2023
5
February 24, 2021
February 22, 2023
5
February 24, 2021
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined