P21v/5-1 MHz P18800

GUDID 00841517105181

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517105181
NIH Device Record Key06880569-5bdc-43c8-876c-6b26158be579
Commercial Distribution StatusIn Commercial Distribution
Brand NameP21v/5-1 MHz
Version Model NumberP18800-51
Catalog NumberP18800
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
GS100841517105181 [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 [P21v/5-1 MHz]

00841517104030Diagnostic Ultrasound Transducer
00841517104023Diagnostic Ultrasound Transducer
00841517103958Diagnostic Ultrasound Transducer
00841517101992Diagnostic Ultrasound Transducer
00841517101893Diagnostic Ultrasound Transducer
00841517101428Diagnostic Ultrasound Transducer
00841517105181P18800-51
00841517106676Diagnostic Ultrasound Transducer
00841517107222P26081-02
00841517108564Diagnostic Ultrasound Transducer

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