Vela 09534

GUDID 10846446001709

Bacteria Filter

Carefusion Corporation

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 10846446001709
• NIH Device Record Key: 1e1ad4ec-2445-44c5-88ce-cd84f894417e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vela
• Version Model Number: 09534
• Catalog Number: 09534
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846446001709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093094

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-12-22
• Device Publish Date: 2017-05-01

On-Brand Devices [Vela]

• 70846446063785: Circuit tubing, 18" smooth bore, pack of 10
• 70846446033368: 22 mm ID cuff adapter, pack of 10
• 70846446010130: Circuit tubing, 18" smooth bore, pack of 10
• 70846446001268: Ped/Adult Airway Adapter
• 10846446001693: VELA Diamond pediatric breathing circuit kit
• 10846446001686: PATIENT BREATHING CIRCUIT,ADULT,VELA DIAMOND
• 10846446001679: PATIENT BREATHING CIRCUIT,VELA
• 10846446001242: Pediatric/Adult Airway Adapter
• 10846446001709: Bacteria Filter
• 10846446012774: KIT,ET-CO2 MODULE
• 10846446012705: KIT,ET-CO2 MODULE W/SOFTWARE
• 10846446011258: KIT,OXIMETER MOUNT-VELA
• 10846446010954: STAND ASSY,TRANSPORT,VELA DIAMOND
• 10846446010930: STAND,BASIC-VELA
• 10846446001716: WTRTRP ASSY LO-RSTNL Y
• 10846446001358: VELA DIAMOND PACKAGE FOR KINDRED HEALTHCARE
• 10846446063912: Stand Assy, Transport
• 10846446005431: Vela Comprehensive Ventilator
• 10846446001600: VELA CF,DISS,GRN O2,TYPE K,ENG OVERLAY
• 10846446001501: VELA CF PLUS,DISS,GRN O2,TYPE K,ENG OVERLAY
• 10846446001419: VELA CF COMP,DISS,GRN O2,TYPE K,ENG