FDA.report

AirLife™

Primary DI
50190752115208
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
002003
Catalog number
002003
Device description
AirLife™ Bubble Humidifier With 3 psi Pressure Relief Valve
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

Related Records

Contact Domains

Product Codes

CodeName
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Product Code Classifications

CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50190752115208PackageGS150In Commercial Distribution
10190752115200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019075211520850190752115208
1019075211520010190752115200

GMDN Terms

TermDefinition
Non-heated respiratory humidifierA device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (reservoir) for the water, a top piece that functions as a detachable lid (typically a screw lid with a gastight seal), and a tube that protrudes into the water to divert the gas below the water level. This device, commonly known as a bubble humidifier, does not heat the water. It has connectors: 1) one (e.g., a winged nut) that connects to an oxygen therapy flowmeter; and 2) one to which the patient tubing is connected. This is a reusable device.

Sterilization Methods

Method

Contacts

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 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 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