HFL38xi/13-6 MHz

GUDID 00841517100360

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100360
NIH Device Record Keyc88b5610-dc85-4023-8687-e2560a367921
Commercial Distribution StatusIn Commercial Distribution
Brand NameHFL38xi/13-6 MHz
Version Model NumberP20311-10
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

Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100360 [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 Date2016-09-13

On-Brand Devices [HFL38xi/13-6 MHz]

00841517104825Diagnostic Ultrasound Transducer
00841517104818Diagnostic Ultrasound Transducer
00841517100377Diagnostic Ultrasound Transducer
00841517100360Diagnostic Ultrasound Transducer
00841517105624P20311-20A
00841517106133Diagnostic Ultrasound Transducer
00841517107178Diagnostic Ultrasound Transducer
00841517109035Diagnostic Ultrasound Transducer
00841517109028Diagnostic Ultrasound Transducer
00841517110475Diagnostic Ultrasound Transducer
00841517110444Diagnostic Ultrasound Transducer

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