FDA.reportPublic FDA data

AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g

Primary DI
00361938122029
Brand
AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g
Company
ONY Biotech Inc.
Model
AVMed
Catalog number
AVMed
Device description
6-Pack of AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g
Published
2025-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00361938122029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00361938122029003619381220293619381220290361938122029

GMDN Terms#

Term, Definition table
TermDefinition
Oropharyngeal airway, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Ambient

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7166369096info@onybiotech.com

Regulatory Flags#

DUNS number
119447554
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00361938122012AerVia Neonatal Supraglottic Airway Device, Small, <1000gAVSmallAVSmall2025-04-01
00361938122036AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500gAVLargeAVLarge2025-04-01
00361938122043AerVia Neonatal Supraglottic Airway Device, X-Large, 3500-5000gAVXLAVXL2025-04-01
00361938122050AerVia Neonatal Supraglottic Airway Device, VarietyAVVarietyAVVariety2025-04-01

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Primary DI, Brand, Company table
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