AVEA

GUDID 10846446017564

AVEA NIMV+VG SW KEY

Carefusion Corporation

Ventilator application software

• Primary Device ID: 10846446017564
• NIH Device Record Key: dbfbdf05-08d5-4682-8fdb-d0733236a5d3
• Commercial Distribution Discontinuation: 2022-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AVEA
• Version Model Number: 63865
• 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: 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.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	10846446017564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103211

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: 2024-05-23
• Device Publish Date: 2017-03-31

On-Brand Devices [AVEA]

• 70846446060395: ESOPHAGEAL PRESSURE MONITORING TUBE SET, 8FR ADULT, BX 10
• 70846446001275: Neonatal/Pediatric Airway Adapter/ Single Patient Use
• 20846446001256: AVEA DISP FILT/WTR-TRP, BOX OF 12
• 10846446001174: PATIENT BREATING CIRCUIT "48"
• 10846446001143: PATIENT BREATING CIRCUIT "72"
• 10846446015966: CONN ASSY,PROX,SMART,10 PACK
• 10846446015973: HOSE ASSY, HELIOX, 15 FT, FEM/FEM
• 10846446065862: TWIN TUBE HOLDER,PATIENT ARM
• 10846446063745: KIT,NEBULIZER MOUNT
• 10846446019605: Tracheal catheter (1)
• 10846446018219: CONNECTIVITY ACCESSORY KIT
• 10846446018103: ARM,PATIENT,CIRCUIT HOLDER
• 10846446017564: AVEA NIMV+VG SW KEY
• 10846446015065: TWIN TUBE HOLDER,PATIENT ARM,PKG OF 3
• 10846446014938: RACK, TANK, CART ASSY, AVEA
• 10846446014921: TRAY,BATTERY,CART ASSEMBLY,AVEA
• 10846446012132: KIT,AVEA,OPTION,PFLEX
• 10846446012118: KIT,AVEA,PHILIPS VUELINK INTFC
• 10846446012033: KIT,INDEPENDENT LUNG VENT CABLE
• 10846446011043: AVEA CAPNOGRAPHY KIT
• 10846446005455: STANDARD CART ASSEMBLY
• 10846446001204: FILTER, DISPOSABLE, 12 PACK-34061
• 10846446001198: HOTWIRE FLOW, SENSOR, NEONATAL
• 10846446001099: NEONATAL ADAPTERS
• 10846446001082: PRESSURE REGULATOR,CALIBRATION GAS
• 10846446000993: RE-USEABLE AIRWAY ADAPTER,NEO/PED
• 10846446000979: KIT,AVEA UPGRADE UIM & SOFTWARE
• 10846446063899: CART ASSEMBLY,AVEA
• 10846446010817: KIT,ACCESS,CUSTOM CART, AVEA
• 10846446010114: BRKT,ASY,CRKT SUPPORT
• 10846446064872: KIT,AVEA UPGRADE GDE & SOFTWARE
• 10846446064865: KIT,AVEA UPGRADE GDE,UIM & SOFTWARE
• 10846446063660: Kit, Heliox male DISS fittings
• 10846446063240: Capnostat 5 Reusable ETCO2 Sensor
• 10846446018301: ESOPHAGEAL PRESSURE MONITORING TUBE SET,5FR PED,BX
• 10846446018295: NASOGASTRIC PRESSURE MON TUBE SET, 7FR PED, BX 10
• 10846446017212: SUPPORT ARM RAIL CLAMP
• 10846446016598: FLOW SENSOR ASSY, ADULT, DISP, WYE
• 10846446016093: TUBE HANGER
• 10846446015935: EXTENSION, ESOPHAGEAL PRESSURE MONITORING TUBE SET
• 10846446015928: Avea Ventilator Extension Esophageal Pressure Monitoring Tube Set
• 10846446014372: ESOPHAGEAL PRESSURE MONITORING TUBE SET,8FR ADULT
• 10846446012125: KIT,AVEA,OPTION,HELIOX,DISS
• 10846446005424: EXTENSION TUBE, TRACHEAL, 10 PACK
• 10846446005332: ADAPTER, TRACHEAL PRESSURE MONITORING, TUBE SET, 5FR
• 10846446005325: FLOW SENSOR ASSY, NEW, DISP, WYE
• 10846446002683: NASOGASTRIC PRESSURE MONITORING TUBE SET,16FR ADULT
• 10846446001792: ESOPHAGEAL PRESSURE MONITORING TUBE SET, 6FR PED, BX 10
• 10846446001181: WATER TRAP ASSY
• 10846446001167: FLOW SENSOR ASSY, NEO DISP, 10PK