AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g AVLarge

GUDID 00361938122036

6-Pack of AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g

ONY Biotech Inc.

Oropharyngeal airway, single-use

• Primary Device ID: 00361938122036
• NIH Device Record Key: 140500d2-5689-4f4a-951c-fe7f57a9a0fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g
• Version Model Number: AVLarge
• Catalog Number: AVLarge
• Company DUNS: 119447554
• Company Name: ONY Biotech Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com
• Phone: 7166369096
• Email: info@onybiotech.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Ambient

Device Identifiers

Device Issuing Agency	Device ID
GS1	00361938122036 [Primary]

FDA Product Code

• CAE: Airway, Oropharyngeal, Anesthesiology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-09
• Device Publish Date: 2025-04-01

Devices Manufactured by ONY Biotech Inc.

• 00361938122012 - AerVia Neonatal Supraglottic Airway Device, Small, <1000g: 2025-04-09 6-Pack of AerVia Neonatal Supraglottic Airway Device, Small,
• 00361938122029 - AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g: 2025-04-09 6-Pack of AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g
• 00361938122036 - AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g: 2025-04-096-Pack of AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g
• 00361938122036 - AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g: 2025-04-09 6-Pack of AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g
• 00361938122043 - AerVia Neonatal Supraglottic Airway Device, X-Large, 3500-5000g: 2025-04-09 6-Pack of AerVia Neonatal Supraglottic Airway Device, X-Large, 3500-5000g
• 00361938122050 - AerVia Neonatal Supraglottic Airway Device, Variety: 2025-04-09 AerVia Neonatal Supraglottic Airway Device, Variety [1 Small, 2 Medium, 2 Large, 1 X-Large]