Vevo MD Imaging System 51475

GUDID 00841517103248

Diagnostic ultrasound system

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517103248
NIH Device Record Key463dfb8a-6e09-419e-a625-7d84ea83a014
Commercial Distribution StatusIn Commercial Distribution
Brand NameVevo MD Imaging System
Version Model Number51475-40
Catalog Number51475
Company DUNS014438860
Company NameFUJIFILM SONOSITE, 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 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+1(999)999-9999
Emailxyz@xyz.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517103248 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-10-24

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