AccessGUDID - DEVICE: QBit Series Diagnostic Ultrasound System (06945121403245)

GUDID

Device Identifier (DI) Information

Brand Name: QBit Series Diagnostic Ultrasound System
Version or Model: QBit 7
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHISON Medical Technologies Co., Ltd.

Primary DI Number: 06945121403245
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?
41917	Foetal Doppler system probe	A hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYN	System, Imaging, Pulsed Doppler, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150861	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: 242815a4-4386-4aea-90bd-898c94c00b17
Public Version Date: November 28, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
06945121405195	1	06945121403245	In Commercial Distribution
06945121405188	1	06945121403245	In Commercial Distribution
06945121405171	1	06945121403245	In Commercial Distribution
06945121405041	1	06945121403245	In Commercial Distribution
06945121405034	1	06945121403245	In Commercial Distribution
06945121405027	1	06945121403245	In Commercial Distribution
06945121405010	1	06945121403245	In Commercial Distribution
06945121405003	1	06945121403245	In Commercial Distribution
06945121404990	1	06945121403245	In Commercial Distribution
06945121404983	1	06945121403245	In Commercial Distribution
06945121404976	1	06945121403245	In Commercial Distribution
06945121404969	1	06945121403245	In Commercial Distribution
06945121404952	1	06945121403245	In Commercial Distribution
06945121404945	1	06945121403245	In Commercial Distribution
06945121404938	1	06945121403245	In Commercial Distribution
06945121405058	1	06945121403245	In Commercial Distribution
06945121405065	1	06945121403245	In Commercial Distribution
06945121405072	1	06945121403245	In Commercial Distribution
06945121405089	1	06945121403245	In Commercial Distribution
06945121405096	1	06945121403245	In Commercial Distribution
06945121405102	1	06945121403245	In Commercial Distribution
06945121405119	1	06945121403245	In Commercial Distribution
06945121405126	1	06945121403245	In Commercial Distribution
06945121405133	1	06945121403245	In Commercial Distribution
06945121405140	1	06945121403245	In Commercial Distribution
06945121405157	1	06945121403245	In Commercial Distribution
06945121405164	1	06945121403245	In Commercial Distribution