FDA.reportPublic FDA data

AirLife™

Primary DI
50190752146318
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
2K8050
Catalog number
2K8050
Device description
AirLife Disposable Face Mask
Published
2022-08-22
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSJMASK, GAS, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752146318PackageGS120In Commercial Distribution
10190752146310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075214631850190752146318
1019075214631010190752146310

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, single-useA non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. 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
false
Expiration date on label
true
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
04816415501287BREATHING MASK Single Use Size 0ASSOMEDIKA, OOOBSJ2026-05-26
04816415501294BREATHING MASK Single Use Size 3ASSOMEDIKA, OOOBSJ2026-05-26
04816415501300BREATHING MASK Single Use Size 6ASSOMEDIKA, OOOBSJ2026-05-26
04816415501317BREATHING MASK Reusable Size 0ASSOMEDIKA, OOOBSJ2026-05-26
04816415501324BREATHING MASK Reusable Size 3ASSOMEDIKA, OOOBSJ2026-05-26
04816415501331BREATHING MASK Reusable Size 5ASSOMEDIKA, OOOBSJ2026-05-26
50192253071410CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071427CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071434CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071441CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071458CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071465CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
44710810080836N/AGALEMED CORPORATIONBSJ2026-03-05
44710810081789N/AGALEMED CORPORATIONBSJ2026-03-05
44710810081819N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082250N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082267N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082403N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082410N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082427N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082489N/AGALEMED CORPORATIONBSJ2026-03-05
44710810086449N/AGALEMED CORPORATIONBSJ2026-03-05
44710810088702N/AGALEMED CORPORATIONBSJ2026-03-05
44710810115781N/AGALEMED CORPORATIONBSJ2026-03-05
44710810117631N/AGALEMED CORPORATIONBSJ2026-03-05
44710810117624N/AGALEMED CORPORATIONBSJ2026-03-04
05030267124084ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15MIntersurgical IncorporatedBSJ2025-09-25
05030267124091ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15MIntersurgical IncorporatedBSJ2025-09-25
05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22FIntersurgical IncorporatedBSJ2025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22FIntersurgical IncorporatedBSJ2025-09-25