SomnoStar 31759-001

GUDID 10846446066050

SWR KIT, SOMNOSTAR 11.2 HOTFIX

Carefusion Corporation

Sleep disorder interpretive software

• Primary Device ID: 10846446066050
• NIH Device Record Key: 0fb14176-e915-45dc-80a5-ecf9b30d433e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SomnoStar
• Version Model Number: 31759-001
• Catalog Number: 31759-001
• Company DUNS: 830432451
• Company Name: Carefusion Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.231.2466
• Email: SUPPORT.SLEEP.US@CAREFUSION.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846446066050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012085

FDA Product Code

• OLV: Standard Polysomnograph With Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-11
• Device Publish Date: 2017-08-10

On-Brand Devices [SomnoStar]

• 10846446033298: SOMNOSTAR 11 UPGRADE
• 10846446066050: SWR KIT, SOMNOSTAR 11.2 HOTFIX
• 10846446065046: CD,SOMNOSTAR VER 11.1
• 10846446033328: CD, LabManager HL7 Hotfix
• 10846446033274: SWR KIT SOMNOSTAR VER 11 SWR BUNDLE FIRST LIC
• 10846446033267: SOMNOSTAR SECURITY ADMIN
• 10846446033250: SWR,KIT SOMNOSTAR 10.2 VID UPG
• 10846446032628: SWR KIT RPT CENTER SSPRO VER 11
• 10846446032611: SWR KIT SSPRO NEW SYS VER 11
• 10846446032550: SWR KIT SSPRO SOFTWARE VER 11
• 10846446032260: SOFTWARE KIT LABMANAGER SQL PATCH
• 10846446032208: LABMANAGER WORD 2013 REPORT HOTFIX CD
• 10846446032185: SWR KIT SSPRO NEW SYS VER 10
• 10846446031485: SWR KIT SSPRO SOFTWARE VER 10.2
• 10846446025415: SWR KIT RPT CENTER SSPRO VER 10
• 10846446021080: SWR KIT LABMGR SQL SETUP WIZARD
• 10846446020274: SWR KIT SSPRO SOFTWARE VER 9
• 10846446024913: PWR SPLY/+15V 50W PSU V32