rC60xi/5-2 MHz

GUDID 00841517100568

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100568
NIH Device Record Key3f99f44e-61fa-45b6-bb97-35455be66d36
Commercial Distribution StatusIn Commercial Distribution
Brand NamerC60xi/5-2 MHz
Version Model NumberP21070-10
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

Storage Environment TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100568 [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 [rC60xi/5-2 MHz]

00841517105587Diagnostic Ultrasound Transducer
00841517104924Diagnostic Ultrasound Transducer
00841517103637Diagnostic Ultrasound Transducer
00841517103620Diagnostic Ultrasound Transducer
00841517103347Diagnostic Ultrasound Transducer
00841517100575Diagnostic Ultrasound Transducer
00841517100568Diagnostic Ultrasound Transducer
00841517107130Diagnostic Ultrasound Transducer
00841517109929Diagnostic Ultrasound Transducer
00841517109073Diagnostic ultrasound transducer
00841517110482Diagnostic Ultrasound Transducer

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