DEVICE: XBit Series Digital Color Doppler Ultrasound System (06945121413459)

Device Identifier (DI) Information

XBit Series Digital Color Doppler Ultrasound System
XBit 90
In Commercial Distribution

CHISON Medical Technologies Co., Ltd.
06945121413459
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 [?]
K200780 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

8e019f11-f3dd-4560-95b7-90144d59bdb9
November 26, 2024
9
November 02, 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
06945121413480 1 06945121413459 In Commercial Distribution
06945121413619 1 06945121413459 In Commercial Distribution
06945121413633 1 06945121413459 In Commercial Distribution
06945121413732 1 06945121413459 In Commercial Distribution
06945121413749 1 06945121413459 In Commercial Distribution
06945121413756 1 06945121413459 In Commercial Distribution
06945121414043 1 06945121413459 In Commercial Distribution
06945121414050 1 06945121413459 In Commercial Distribution
06945121414104 1 06945121413459 In Commercial Distribution
06945121414067 1 06945121413459 In Commercial Distribution
06945121414111 1 06945121413459 In Commercial Distribution
06945121414074 1 06945121413459 In Commercial Distribution
06945121414128 1 06945121413459 In Commercial Distribution
06945121414081 1 06945121413459 In Commercial Distribution
06945121414098 1 06945121413459 In Commercial Distribution
06945121414142 1 06945121413459 In Commercial Distribution
06945121414203 1 06945121413459 In Commercial Distribution
06945121414708 1 06945121413459 In Commercial Distribution
06945121415569 1 06945121413459 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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