Avea

GUDID 10190752185685

AVEA STD,N/CMP,ENG 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 Neonatal/adult intensive-care ventilator

• Primary Device ID: 10190752185685
• NIH Device Record Key: 2b9a2e15-f370-4bfd-9f9a-5c3e82645878
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avea
• Version Model Number: 17311-00
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752185685 [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: 2024-03-28
• Device Publish Date: 2024-03-20

On-Brand Devices [Avea]

• 10190752156227: AVEA Ventilator Espohageal Pressure Monitoring Tube Set, 6 FR Adult
• 10190752167629: RESPITRACE Q.D.C.
• 10190752163300: GAS & HOSE KIT TABLE VMAX 22
• 10190752162549: REGULATOR O2 0-80 PSIG CGA 870
• 10190752167117: AVEA, COMPREHENSIVE GENERIC
• 10190752159075: KIT, AVEA UPGRADE GDE & SOFTWARE
• 10846446011913: BATTERY, 2 PACK, AVEA
• 10190752177048: FLOW SENSOR,INSPIRATORY ASSEMBLY
• 10190752174801: BATTERY ASSEMBLY, 24V, 4.5AH, NIMH, AVEA
• 10190752157767: AVEA Ventilator
• 10190752164055: SPECTRA MAX PRESSURE OPTN CRYP
• 10190752186439: AVEA Ventilator
• 20190752156231: AVEA Ventilator Nasogastric Pressure Monitoring Tub Set, 7 FR Pediatric
• 10190752186248: AVEA II Ventilator - Avea Refresh
• 10190752185784: AVEA STD,W/CMP,ENG LNG,LO V,DISS,K
• 10190752185685: AVEA STD,N/CMP,ENG LNG,LO V,DISS,K