SP5-1Ns Ultrasonic Probe(FDA)

GUDID 06936415925918

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID06936415925918
NIH Device Record Key25e13736-1461-41d0-8639-a1e486554a1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSP5-1Ns Ultrasonic Probe(FDA)
Version Model Number120-013737-00
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 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
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn
Phone+8675581888998
Emailservice@mindray.com.cn

Device Identifiers

Device Issuing AgencyDevice ID
GS106936415925918 [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 Date2020-12-07
Device Publish Date2020-11-29

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

06944904031408 - BC-6D Hematology Control2023-10-27
06944904031422 - BC-RET Hematology Control2023-10-27
06903053039673 - L9-3s Transducer(FDA-SJM)2023-05-30
06903053039680 - P8-2Ts Transducer(FDA-SJM)2023-05-30
06903053039697 - SP5-1s Transducer(FDA-SJM)2023-05-30
06903053039703 - P8-2s Transducer(FDA-SJM)2023-05-30
06903053039710 - CW2s Transducer(FDA-SJM)2023-05-30
06903053039727 - L16-4Hs Transducer(FDA-SJM)2023-05-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.