SonoSite iViz P20830

GUDID 00841517104719

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517104719
NIH Device Record Key8a1af2a0-6abb-47c7-a935-185f87979e01
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoSite iViz
Version Model NumberP20830-26
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104719 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-30
Device Publish Date2020-06-22

On-Brand Devices [SonoSite iViz]

00841517104566Diagnostic ultrasound system
00841517103842Diagnostic ultrasound system
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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