P21n/5-1 MHz

GUDID 00841517100865

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100865
NIH Device Record Keya94f4efa-76b6-44d5-a7d8-c65f45500a67
Commercial Distribution StatusIn Commercial Distribution
Brand NameP21n/5-1 MHz
Version Model NumberP11879-70A
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
GS100841517100865 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-14

On-Brand Devices [P21n/5-1 MHz]

00841517104603Diagnostic Ultrasound Transducer
00841517104269Diagnostic Ultrasound Transducer
00841517104252Diagnostic Ultrasound Transducer
00841517104146Diagnostic Ultrasound Transducer
00841517104139Diagnostic Ultrasound Transducer
00841517101367Diagnostic Ultrasound Transducer
00841517101350Diagnostic Ultrasound Transducer
00841517100872Diagnostic Ultrasound Transducer
00841517100865Diagnostic Ultrasound Transducer
00841517100858Diagnostic Ultrasound Transducer

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