Somnostar 28477-001

GUDID 10846446032611

SWR KIT SSPRO NEW SYS VER 11

Carefusion Corporation

Sleep disorder interpretive software
Primary Device ID10846446032611
NIH Device Record Key188a7647-9e8f-4ec5-b072-42203a0b93a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSomnostar
Version Model Number28477-001
Catalog Number28477-001
Company DUNS830432451
Company NameCarefusion Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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

Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com
Phone800.231.2466
Emailsupport.sleep.us@carefusion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110846446032611 [Primary]

FDA Product Code

OLVStandard Polysomnograph With Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-09-13

On-Brand Devices [Somnostar]

10846446033298SOMNOSTAR 11 UPGRADE
10846446066050SWR KIT, SOMNOSTAR 11.2 HOTFIX
10846446065046CD,SOMNOSTAR VER 11.1
10846446033328CD, LabManager HL7 Hotfix
10846446033274SWR KIT SOMNOSTAR VER 11 SWR BUNDLE FIRST LIC
10846446033267SOMNOSTAR SECURITY ADMIN
10846446033250SWR,KIT SOMNOSTAR 10.2 VID UPG
10846446032628SWR KIT RPT CENTER SSPRO VER 11
10846446032611SWR KIT SSPRO NEW SYS VER 11
10846446032550SWR KIT SSPRO SOFTWARE VER 11
10846446032260SOFTWARE KIT LABMANAGER SQL PATCH
10846446032208LABMANAGER WORD 2013 REPORT HOTFIX CD
10846446032185SWR KIT SSPRO NEW SYS VER 10
10846446031485SWR KIT SSPRO SOFTWARE VER 10.2
10846446025415SWR KIT RPT CENTER SSPRO VER 10
10846446021080SWR KIT LABMGR SQL SETUP WIZARD
10846446020274SWR KIT SSPRO SOFTWARE VER 9
10846446024913PWR SPLY/+15V 50W PSU V32
10846446020151CABLE ASSY,OVERMOLD,50 PIN,HEADBOX
10846446020144ASSY/AMP SLEEP RC 9.1+
10846446020076HEADBOX ASSEMBLY
10846446033243SOMNOSTAR 10.2 VIDEO UPGRADE KIT
10846446032604SOMNOSTAR Z4 SYSTEM VER 11
10846446032598ACQ STN 1 BED Z4 VER 11
10846446025422SOMNOSTAR Z4 SYSTEM VER 10
10846446025392ACQ STN 1 BED Z4 VER 10

Trademark Results [Somnostar]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOMNOSTAR
SOMNOSTAR
75126859 2117557 Live/Registered
SENSORMEDICS CORPORATION
1996-06-28
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