AccessGUDID - DEVICE: ECO Series Diagnostic Ultrasound Systems (06945121407328)

GUDID

Device Identifier (DI) Information

Brand Name: ECO Series Diagnostic Ultrasound Systems
Version or Model: ECO 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHISON Medical Technologies Co., Ltd.

Primary DI Number: 06945121407328
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 [?]
K131305	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: 7dfe2eb6-947e-4405-b9e8-8367ed53f240
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
06945121407991	1	06945121407328	In Commercial Distribution
06945121407984	1	06945121407328	In Commercial Distribution
06945121407977	1	06945121407328	In Commercial Distribution
06945121407960	1	06945121407328	In Commercial Distribution
06945121407953	1	06945121407328	In Commercial Distribution
06945121407946	1	06945121407328	In Commercial Distribution
06945121407939	1	06945121407328	In Commercial Distribution
06945121407922	1	06945121407328	In Commercial Distribution