SonoSite Edge II

GUDID 00841517104443

Diagnostic ultrasound system

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517104443
NIH Device Record Key7424e3f0-31a9-4773-ac1a-c18d28949071
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoSite Edge II
Version Model NumberP20680-17
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

Phone+1(999)999-9999
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *N/A

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, imaging, pulsed doppler, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-02
Device Publish Date2019-01-15

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