DC-80A Diagnostic Ultrasound System

GUDID 06936415910389

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06936415910389
NIH Device Record Key6f6d11be-d6e0-44e2-af0a-17dd8fd8d6a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDC-80A Diagnostic Ultrasound System
Version Model NumberDC-80A
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106936415910389 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-26
Device Publish Date2025-02-18

Devices Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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06903053001793 - ZS3KP Elite Diagnostic Ultrasound System2025-02-26
06903053001809 - ZS4 Diagnostic Ultrasound System2025-02-26
06936415910389 - DC-80A Diagnostic Ultrasound System2025-02-26
06936415910389 - DC-80A Diagnostic Ultrasound System2025-02-26
06936415912499 - DC-65 Diagnostic Ultrasound System2025-02-26
06936415925628 - DC-80A Exp Diagnostic Ultrasound System2025-02-26
06936415925635 - DC-80A Pro Diagnostic Ultrasound System2025-02-26
06936415925642 - DC-81 Diagnostic Ultrasound System2025-02-26
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