SonoSite S-Series P28962

GUDID 00841517105730

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517105730
NIH Device Record Keybf904d37-0885-4667-b72f-b97291b75ec2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoSite S-Series
Version Model NumberP28962-95
Catalog NumberP28962
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

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517105730 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-05
Device Publish Date2020-04-27

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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