FDA.reportPublic FDA data

AirLife™

Primary DI
50190752144543
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
132410
Catalog number
132410
Device description
AirLife™ Mouthpiece, small 22 mm ID
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
BYPMOUTHPIECE, BREATHING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752144543PackageGS1500In Commercial Distribution
10190752144545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075214454350190752144543
1019075214454510190752144545

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
true
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
08904461055024OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
46923980103672N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
20197344011312HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
04250892907321JaegerJaeger Medical GmbHBYP2025-06-02
04250892907383JaegerJaeger Medical GmbHBYP2025-06-02
30889483573451AirLife™Sunmed Group Holdings, LLCBYP2025-03-27
30889483569164AirLife™Sunmed Group Holdings, LLCBYP2025-03-18
30889483569195AirLife™Sunmed Group Holdings, LLCBYP2025-03-18
00817081028232Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleA-M SYSTEMS, LLCBYP2025-02-21
00817081028256Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingA-M SYSTEMS, LLCBYP2025-02-21
14250892906833VyaireVyaire Medical GmbHBYP2025-01-07
14250892906840VyaireVyaire Medical GmbHBYP2025-01-07
14250892906857VyaireVyaire Medical GmbHBYP2025-01-07
14250892906864VyaireVyaire Medical GmbHBYP2025-01-07
07613365500110SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500134SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500196SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
00026072026304BFAllied Medical, LLCBYP2024-10-11
08052990320219MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
08052990321179MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
08052990321834MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
10197344103737MEDLINEMEDLINE INDUSTRIES, INC.BYP2024-07-22
00026072026243BFAllied Medical, LLCBYP2024-05-28
00026072026298BFAllied Medical, LLCBYP2024-05-28
B279F037005001Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279F037020002Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S29807005001Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S29807020002Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
00817081027686Adapter, Tube, Sample PackA-M SYSTEMS, LLCBYP2023-11-21
10384620000730InFloConeALLIANCE TECH MEDICAL INCBYP2023-09-08