Color Doppler Ultrasound System

GUDID 06972174670027

Shenzhen Well.D Medical Electronics Co.,Ltd.

General-purpose ultrasound imaging system
Primary Device ID06972174670027
NIH Device Record Keyae90d5d8-055d-470e-b5cf-5d5273c868cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameColor Doppler Ultrasound System
Version Model NumbermEye2
Company DUNS421472085
Company NameShenzhen Well.D Medical Electronics Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972174670027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-28
Device Publish Date2019-01-28

On-Brand Devices [Color Doppler Ultrasound System]

06972174670027mEye2
06972174670010mEye1

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