SII Stand P21432

GUDID 00841517102159

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517102159
NIH Device Record Keyb2e46fba-a8c3-4b47-8689-f38121820d63
Commercial Distribution StatusIn Commercial Distribution
Brand NameSII Stand
Version Model NumberP21432-06
Catalog NumberP21432
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

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517102159 [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 Date2017-04-28

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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