AerVia Neonatal Supraglottic Airway Device, Small, <1000g

Basic Information

• Brand Name: AerVia Neonatal Supraglottic Airway Device, Small, <1000g
• Primary DI: 00361938122012
• Version / Model: AVSmall
• Catalog Number: AVSmall
• Company Name: ONY Biotech Inc.
• Labeler DUNS: 119447554
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-01
• Public Version: 1
• Public Version Date: 2025-04-09
• Public Version Status: New
• Public Device Record Key: c2e3328c-e59a-4f48-9079-fa62c3c60245

Device Description

6-Pack of AerVia Neonatal Supraglottic Airway Device, Small, <1000g

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	868.5110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42424	Oropharyngeal airway, single-use	A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00361938122012	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Ambient