DP-10 Diagnostic Ultrasound System

GUDID 06944904030531

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06944904030531
NIH Device Record Keyf3b3eded-bd1a-4563-8900-27394f454c24
Commercial Distribution StatusIn Commercial Distribution
Brand NameDP-10 Diagnostic Ultrasound System
Version Model NumberDP-10
Company DUNS654671304
Company NameShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone+8675581888998
Emailservice@mindray.com.cn

Device Identifiers

Device Issuing AgencyDevice ID
GS106936415900199 [Unit of Use]
GS106944904030531 [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 Number2
Public Version Date2020-04-27
Device Publish Date2019-10-28

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