SonoSite iViz P20830

GUDID 00841517101442

Diagnostic ultrasound system

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517101442
NIH Device Record Key35cef324-08e4-4979-90fd-0c65f27b401d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoSite iViz
Version Model NumberP20830-17
Catalog NumberP20830
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 -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517101442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, 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 Date2016-09-23

On-Brand Devices [SonoSite iViz]

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00841517103835Diagnostic ultrasound system
00841517103712Diagnostic ultrasound system
00841517102203Diagnostic ultrasound system
00841517101862Diagnostic ultrasound system
00841517101855Diagnostic ultrasound system
00841517101671Diagnostic ultrasound system
00841517101572Diagnostic ultrasound system
00841517101442Diagnostic ultrasound system
00841517101206Diagnostic ultrasound system
00841517100896Diagnostic ultrasound system
00841517104719P20830-26
00841517104313Diagnostic ultrasound system
008415171074681

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