FDA.reportPublic FDA data

AirLife™

Primary DI
50190752144796
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
002002
Catalog number
002002
Device description
AirLife™ Nebulizer with Air Entrainment
Published
2020-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752144796PackageGS124In Commercial Distribution
10190752144798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075214479650190752144796
1019075214479810190752144798

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
080456871
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752190535LTV10611106112025-08-26
10190752191518bellavista301.115.010301.115.0102025-07-28
10190752188860bellavista301.115.000301.115.0002025-07-25
10190752191525bellavista301.115.020301.115.0202025-07-25
10190752130364LTV2 Ventilator30509-00130509-0012025-07-16
201907522010613100A HFOV7671637671632025-07-16
10190752185197LTV228774-00128774-0012025-07-16
10190752188754LTV2 Ventilator24425-00124425-0012025-07-16
10190752188761LTV2 Ventilator24426-00124426-0012025-07-16
10190752188808LTV2 Ventilator30512-00130512-0012025-07-16
10190752190368LTV2 Ventilator29242-00129242-0012025-07-16
10190752187818iFlow301.328.020301.328.0202024-11-05
50190752187823iFlow301.328.020301.328.0202024-11-05
50190752200805LTV29660-00129660-0012024-11-05
50190752200829LTV29701-00129701-0012024-11-05
101907522010193100 HFOV11438-PMN11438-PMN2024-11-05
10190752201118LTV10696106962024-11-05
50190752201536LTV11872x1011872x102024-11-05
50190752200751LTV29659-00129659-0012024-08-13
10190752201446LTV15091-10215091-1022024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
64897132250476TECMEVINCENT HEALTHCARE PRODUCTS LIMITEDBTT2026-03-17
64897132250315inspired™VINCENT HEALTHCARE PRODUCTS LIMITEDBTT2026-03-05
30889483631472AirLifeSUNMED, LLCBTT2026-02-27
09420012481757F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481801F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481825F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
10197344007165HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-03
20197344005991HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-02
20197344009722HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
10889483648162AirLife™AIRLIFEBTT2026-01-14
20197344009821HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009852HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009869HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009876HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029706HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029713HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029720HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009586HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344009845HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344011022HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344011053HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
54026704734097HUDSON RCITELEFLEX INCORPORATEDBTT2025-06-04
54026704734103HUDSON RCITELEFLEX INCORPORATEDBTT2025-06-04
07321820069774Vivo 1/2, Vivo 3Breas Medical ABBTT2025-05-19
10889483631416AirLife™AIRLIFEBTT2025-04-21
10889483631423AirLife™AIRLIFEBTT2025-04-21
10889483631430AirLife™AIRLIFEBTT2025-04-21
10889483631447AirLife™AIRLIFEBTT2025-04-21
10889483631454AirLife™AIRLIFEBTT2025-04-21
10889483631461AirLife™AIRLIFEBTT2025-04-21