rP19x/5-1 MHz

GUDID 00841517100582

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100582
NIH Device Record Key1b7c0f9d-15ca-4614-83f3-e800550bc608
Commercial Distribution StatusIn Commercial Distribution
Brand NamerP19x/5-1 MHz
Version Model NumberP21015-10
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
GS100841517100582 [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 [rP19x/5-1 MHz]

00841517104948Diagnostic Ultrasound Transducer
00841517100599Diagnostic Ultrasound Transducer
00841517100582Diagnostic Ultrasound Transducer
00841517106140Diagnostic Ultrasound Transducer
00841517107154Diagnostic Ultrasound Transducer
00841517109066Diagnostic Ultrasound Transducer
00841517110574Diagnostic Ultrasound Transducer

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