CW Module Kit

GUDID 06944904053127

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06944904053127
NIH Device Record Key013a804d-7360-4788-8b25-a01194e18597
Commercial Distribution StatusIn Commercial Distribution
Brand NameCW Module Kit
Version Model Number115-024664-00
Company DUNS654671304
Company NameShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+8675581888998
Emailservice@mindray.com.cn

Device Identifiers

Device Issuing AgencyDevice ID
GS106944904053127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, imaging, pulsed doppler, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [CW Module Kit]

06944904089522115-032775-00
06944904053127115-024664-00
06944904036922115-012416-00
06944904033402115-011003-00

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