AVEA™ 17310-00

GUDID 10190752185777

AVEA,CMPRH,BSC LNG,LO V,DISS, K

VYAIRE MEDICAL, INC.

Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator

• Primary Device ID: 10190752185777
• NIH Device Record Key: 7b24d57b-c311-4497-8269-27229adb3b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVEA™
• Version Model Number: 17310-00
• Catalog Number: 17310-00
• Company DUNS: 080456871
• Company Name: VYAIRE MEDICAL, INC.
• 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: 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: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752185777 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-17
• Device Publish Date: 2021-03-09

On-Brand Devices [AVEA™]

• 10190752158313: PATIENT BREATING CIRCUIT "72"
• 10190752156838: AVEA SmartCath™ Extension, Esophageal Pressure Monitoring Tube Set
• 10190752185777: AVEA,CMPRH,BSC LNG,LO V,DISS, K
• 10190752176836: ASSY HUDSON HUMIDIFIER BRACKET
• 10190752175921: AVEA NIMV+VG SW KEY
• 10190752175600: CYLINDER RING SET
• 10190752159051: AVEA Ventilator
• 10190752156814: Ventilator Esophageal Pressure Monitoring Tube Set
• 10190752128668: NEONATAL AIRWAY ADAPTER
• 10190752160385: AVEA, CLIO STD W/CMP, BSC LNG, LO V, DISS K
• 10190752187757: CART ASSEMBLY, AVEA
• 10190752186873: AVEA Ventilator Adapter, Tracheal Pressure Monitoring Tube Set, 5FR, CHINA
• 10190752164840: Patient Circuit, Infant
• 10190752158351: AVEA CAPNOGRAPHY KIT
• 10190752158320: KIT, AVEA, PHILIPS VUELINK INTFC
• 10190752158290: PATIENT BREATING CIRCUIT "48"
• 10190752156258: AVEA™ Ventilator HotWire
• 10190752156210: AVEA Ventilator Nasogastric Pressure Monitoring Tube Set, 16 FR Adult
• 10190752156203: AVEA Ventilator Esophageal Pressure Monitoring Tube Set, 8 FR Adult