SonoSite X-Porte P19220

GUDID 00841517104412

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517104412
NIH Device Record Key42a69dc4-cb43-4c01-a605-ab2db7792c6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoSite X-Porte
Version Model NumberP19220-21
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104412 [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 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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