Transducer mL26-8

GUDID 00884838108592

Philips Ultrasound LLC

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00884838108592
NIH Device Record Key946d9d83-5514-49f3-bc66-62654288a417
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransducer mL26-8
Version Model Number989606722361
Company DUNS063377717
Company NamePhilips Ultrasound LLC
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
GS100884838108592 [Primary]

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 Number4
Public Version Date2025-02-24
Device Publish Date2023-05-22

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00884838126923 - EPIQ Diagnostic Ultrasound System2025-07-01 EPIQ CVx Diagnostic Ultrasound System
00884838126930 - EPIQ Diagnostic Ultrasound System2025-07-01 EPIQ CVxi Diagnostic Ultrasound System
00884838126947 - Affiniti CVx Diagnostic Ultrasound System Circular Edition2025-07-01 Affiniti CVx Diagnostic Ultrasound System Circular Edition
00884838115354 - Ultrasound System 5100 POC2025-05-29 Flash Ultrasound System 5100 POC, release 1.0.
00884838120174 - Ultrasound System 5100 POC Pro2025-05-29 Flash Ultrasound System 5100 POC, release 1.0.
00884838125186 - Ultrasound Workspace2025-04-01

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