AerVia Neonatal Supraglottic Airway Device, Variety AVVariety

GUDID 00361938122050

AerVia Neonatal Supraglottic Airway Device, Variety [1 Small, 2 Medium, 2 Large, 1 X-Large]

ONY Biotech Inc.

Oropharyngeal airway, single-use
Primary Device ID00361938122050
NIH Device Record Key55245cc8-52ec-4a1e-bcac-547954c79e7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAerVia Neonatal Supraglottic Airway Device, Variety
Version Model NumberAVVariety
Catalog NumberAVVariety
Company DUNS119447554
Company NameONY Biotech Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com
Phone7166369096
Emailinfo@onybiotech.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient

Device Identifiers

Device Issuing AgencyDevice ID
GS100361938122050 [Primary]

FDA Product Code

CAEAirway, Oropharyngeal, Anesthesiology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-09
Device Publish Date2025-04-01

Devices Manufactured by ONY Biotech Inc.

00361938122012 - AerVia Neonatal Supraglottic Airway Device, Small, <1000g2025-04-09 6-Pack of AerVia Neonatal Supraglottic Airway Device, Small,
00361938122029 - AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g2025-04-09 6-Pack of AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g
00361938122036 - AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g2025-04-09 6-Pack of AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g
00361938122043 - AerVia Neonatal Supraglottic Airway Device, X-Large, 3500-5000g2025-04-09 6-Pack of AerVia Neonatal Supraglottic Airway Device, X-Large, 3500-5000g
00361938122050 - AerVia Neonatal Supraglottic Airway Device, Variety2025-04-09AerVia Neonatal Supraglottic Airway Device, Variety [1 Small, 2 Medium, 2 Large, 1 X-Large]
00361938122050 - AerVia Neonatal Supraglottic Airway Device, Variety2025-04-09 AerVia Neonatal Supraglottic Airway Device, Variety [1 Small, 2 Medium, 2 Large, 1 X-Large]

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