SII Stand

GUDID 00841517100124

Ultrasound System Accessory

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517100124
NIH Device Record Key127ef5d9-e7e9-40d8-af63-6cf8a8449a81
Commercial Distribution StatusIn Commercial Distribution
Brand NameSII Stand
Version Model NumberP21432-04
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

Phone1-877-657-8118
Emailffss-service@fujifilm.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100124 [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 Date2016-09-12

On-Brand Devices [SII Stand]

00841517102159P21432-06
00841517102081P21432-05
00841517100124Ultrasound System Accessory
00841517105792P21432-50
00841517106454Diagnostic Ultrasound System Accessory
00841517108144SII Accessory
00841517110338DIAGNOSTIC ULTARSOUND ACCESSORY

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