rP19x/5-1 MHz Armored

GUDID 00841517100605

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100605
NIH Device Record Keydf1e72a6-ac1f-474d-8208-e8ac97e6f362
Commercial Distribution StatusIn Commercial Distribution
Brand NamerP19x/5-1 MHz Armored
Version Model NumberP21556-10
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
GS100841517100605 [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 Armored]

00841517105112Diagnostic Ultrasound Transducer
00841517104931Diagnostic Ultrasound Transducer
00841517100605Diagnostic Ultrasound Transducer
00841517107161Diagnostic Ultrasound Transducer
00841517107611P21556-20A
00841517109080Diagnostic Ultrasound Transducer
00841517110420P21556-21A

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