SonoSite S-Series P09417

GUDID 00841517103095

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517103095
NIH Device Record Keye7dddcd4-52fd-407b-b892-62da0a7eadac
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoSite S-Series
Version Model NumberP09417-67R
Catalog NumberP09417
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
Emailxyz@xyz.com

Operating and Storage Conditions

Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517103095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

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 Date2017-10-24

On-Brand Devices [SonoSite S-Series]

00841517105495P09417-71R
00841517105488P09417-95R
00841517103101P09417-68R
00841517103095P09417-67R
00841517103088P09417-66R
00841517103071P09417-65R
00841517103064P09417-57R
00841517102623P09417-92
00841517102616P09417-68
00841517101794P09417-94R
00841517101787P09417-70R
00841517101701P09417-94
00841517101695SONOSITE S SERIES ULTRASOUND SYSTEM, S1.9.2
00841517101312P09417-69R
00841517101305P09417-69
00841517100285P09417-93R
00841517100278P09417-93
00841517105730P28962-95
00841517105716P28962-95R

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