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

GUDID

Device Identifier (DI) Information

Brand Name: CBit Series Digital Color Doppler Ultrasound System
Version or Model: CBit 9
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHISON Medical Technologies Co., Ltd.

Primary DI Number: 06945121413015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544914187 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

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 [?]
K180974	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e606fa7f-9e12-460e-adb0-46e98bec73ee
Public Version Date: February 22, 2023
Public Version Number: 5
DI Record Publish Date: February 24, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
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