FDA.reportPublic FDA data

AirLife™

Primary DI
50190752144772
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
001831
Catalog number
001831
Device description
AirLife™ Adult "Y" Connector with Elbow Thermometer and Pressure Sensing Ports with Caps
Published
2020-01-17
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
BWFSPIROMETER, THERAPEUTIC (INCENTIVE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752144772PackageGS150In Commercial Distribution
10190752144774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075214477250190752144772
1019075214477410190752144774

GMDN Terms#

Term, Definition table
TermDefinition
Tube/mask breathing circuit connector, single-use, non-sterileA non-sterile device intended to connect a breathing circuit breathing tube to an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with standardized connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excluding Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

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
false
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
20197344010339HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
20197344010346HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
20197344010353HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
30889483642317AirLife™SUNMED, LLCBWF2025-07-31
30889483642324AirLife™SUNMED, LLCBWF2025-07-31
20197344097712HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2025-07-23
30889483570696AirLife™Sunmed Group Holdings, LLCBWF2025-02-20
30889483570801AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570818AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570825AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570832AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570849AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
20885632429771HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
20885632429788HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
20885632429795HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
20885632429801HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
00850021574345Breather Med - cRMT McSc Medical, LLCBWF2024-09-09
01240000013856Breather Med - cRMT Basic UDIMcSc Medical, LLCBWF2024-09-09
50604351505129Aerobika,OPEP Monaghan Medical CorporationBWF2024-05-16
40612479269918McKessonMCKESSON MEDICAL-SURGICAL INC.BWF2024-05-14
40612479269932McKessonMCKESSON MEDICAL-SURGICAL INC.BWF2024-05-14
40612479269956McKessonMCKESSON MEDICAL-SURGICAL INC.BWF2024-05-14
00818834028646CuraplexTRI-ANIM HEALTH SERVICES, INC.BWF2024-03-10
00818834028684CuraplexTRI-ANIM HEALTH SERVICES, INC.BWF2024-03-10
20197344007698HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2023-12-18
10190752117129AirLifeVYAIRE MEDICAL, INC.BWF2023-08-04
10190752117143AirLifeVYAIRE MEDICAL, INC.BWF2023-08-04
20888277409146MedlineMEDLINE INDUSTRIES, INC.BWF2022-06-10
20888277409153MedlineMEDLINE INDUSTRIES, INC.BWF2022-06-10
00810094573119CuraplexBOUND TREE MEDICAL, LLCBWF2022-04-30