C6-3 Transducer

GUDID 00884838087170

Philips Ultrasound, Inc.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00884838087170
NIH Device Record Keye190eb74-de01-4b71-8833-c515596e30ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameC6-3 Transducer
Version Model Number989605359594
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
GS100884838087170 [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 Number3
Public Version Date2018-11-12
Device Publish Date2018-03-03

Devices Manufactured by Philips Ultrasound, Inc.

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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

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