L12-5 50 transducer

GUDID 00884838064652

Philips Ultrasound, Inc.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00884838064652
NIH Device Record Key8c67fa86-6445-459b-b667-fd1074a577de
Commercial Distribution StatusIn Commercial Distribution
Brand NameL12-5 50 transducer
Version Model Number989605368803
Company DUNS063377717
Company NamePhilips Ultrasound, Inc.
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 Datefalse
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
GS100884838064652 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-30
Device Publish Date2018-04-21

Devices Manufactured by Philips Ultrasound, Inc.

00884838122277 - QLAB Advanced Quantification Software2024-06-06 VM11.0 update
00884838123960 - EPIQ CVx Diagnostic Ultrasound System2024-06-06 VM11.0 Update
00884838123977 - EPIQ CVxi Diagnostic Ultrasound System2024-06-06 VM 11.0 Update
00884838123984 - Affiniti CVx Diagnostic Ultrasound System2024-06-06 VM11.0 update
00884838114265 - Affinti 30 Diagnostic Ultrasound System Circular Edition2024-06-04 VM10.0 Update
00884838114241 - Affinti 50 Diaagnostic Ultrasound System Circular Edition2024-05-13 Software Version 10.0.2
00884838114258 - Affinti 70 Diaagnostic Ultrasound System Circular Edition2024-05-13 Software Version 10.0.2
00884838114203 - EPIQ 7 Diagnostic Ultrasound System Circular Edition2024-04-18 10.0.X Circular Edition

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