FDA.reportPublic FDA data

AerVia Neonatal Supraglottic Airway Device, Variety

Primary DI
00361938122050
Brand
AerVia Neonatal Supraglottic Airway Device, Variety
Company
ONY Biotech Inc.
Model
AVVariety
Catalog number
AVVariety
Device description
AerVia Neonatal Supraglottic Airway Device, Variety [1 Small, 2 Medium, 2 Large, 1 X-Large]
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
00361938122050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00361938122050003619381220503619381220500361938122050

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
00361938122029AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000gAVMedAVMed2025-04-01
00361938122036AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500gAVLargeAVLarge2025-04-01
00361938122043AerVia Neonatal Supraglottic Airway Device, X-Large, 3500-5000gAVXLAVXL2025-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060112310058LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03
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05060112310041LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
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05060112310638LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310645LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310652LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310683LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
15060112316200LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-30
05060112310072LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
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05060112310096LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310102LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310119LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
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05060112310164LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
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05060112310188LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310195LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310201LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310676LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
10888277699472MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699489MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699496MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699502MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699533MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
15060112314176LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
15060112316132LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29