Somnostar 16610

GUDID 10846446020076

HEADBOX ASSEMBLY

Carefusion Corporation

Polysomnography analyser

• Primary Device ID: 10846446020076
• NIH Device Record Key: ff4d808a-3d11-4e08-a5f1-0ee2bf3901e6
• Commercial Distribution Discontinuation: 2022-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Somnostar
• Version Model Number: 16610
• Catalog Number: 16610
• Company DUNS: 830432451
• Company Name: Carefusion Corporation
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com
• Phone: 800.231.2466
• Email: support.sleep.us@carefusion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846446020076 [Primary]

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: 3
• Public Version Date: 2024-05-23
• Device Publish Date: 2016-09-13

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
• 10846446020151: CABLE ASSY,OVERMOLD,50 PIN,HEADBOX
• 10846446020144: ASSY/AMP SLEEP RC 9.1+
• 10846446020076: HEADBOX ASSEMBLY
• 10846446033243: SOMNOSTAR 10.2 VIDEO UPGRADE KIT
• 10846446032604: SOMNOSTAR Z4 SYSTEM VER 11
• 10846446032598: ACQ STN 1 BED Z4 VER 11
• 10846446025422: SOMNOSTAR Z4 SYSTEM VER 10
• 10846446025392: ACQ STN 1 BED Z4 VER 10