SonoSite X-Porte P19220

GUDID 00841517104436

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517104436
NIH Device Record Key9d232861-635e-4a82-b193-36408f0a5d43
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoSite X-Porte
Version Model NumberP19220-75
Catalog NumberP19220
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
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104436 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-07
Device Publish Date2018-12-06

On-Brand Devices [SonoSite X-Porte]

00841517104740P19220-22
00841517104733P19220-77
00841517104436P19220-75
00841517103415SonoSite X-Porte
00841517103408P19220-20
00841517103392SonoSite X-Porte
00841517103385SonoSite X-Porte
00841517102821P17880-54
00841517102814P17880-11
00841517102807P17880-10
00841517102760P19220-55 
00841517102753P19220-10 
00841517102746P19220-05 
00841517102715P16055-60
00841517102708P16055-56
00841517102692P16055-35
00841517102685P16055-32
00841517101916P19220-65
00841517101909P19220-15
00841517100933P19220-60
00841517100926P17880-55
00841517104412P19220-21
00841517107420P20431-03

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