FDA.report

AirLife™

Primary DI
50190752144802
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
0Y1777
Catalog number
0Y1777
Device description
AirLife™ Ventilator Circuit 2.0 m (6.5') With (3 mm) 1/8" and (6 mm) 1/4" Pressure Lines and Valve Tee. For use with ventilators that have internal exhalation vales.
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
BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Product Code Classifications

CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50190752144802PackageGS110In Commercial Distribution
10190752144804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019075214480250190752144802
1019075214480410190752144804

GMDN Terms

TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use 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
true
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 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
20197344011343HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011350HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011374HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
44710810100329N/AGALEMED CORPORATIONBZO2026-03-05
44710810107311N/AGALEMED CORPORATIONBZO2026-03-04
04719894389189VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
04719894389196VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
04719894389202VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
09420012479112F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479136F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479150F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479174F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
46923980106406N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106413N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106420N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
14719894389162VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
04719894389172VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
20889483225650AirLife™SUNMED, LLCBZO2025-12-19
44710810088405N/AGALEMED CORPORATIONBZO2025-12-18
14719894386314VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386321VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386338VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386345VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386352VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386369VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386376VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386383VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386390VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
44026704388781HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-30
24026704388794HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-30