FDA.reportPublic FDA data

AirLife™

Primary DI
50190752145076
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
9012B
Catalog number
9012B
Device description
AirLife™ bi-directional flow guard PEEP 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYEAttachment, breathing, positive end expiratory pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752145076PackageGS110In Commercial Distribution
10190752145078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075214507650190752145076
1019075214507810190752145078

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
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 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
44710810117464N/AGALEMED CORPORATIONBYE2026-03-05
00856825003159N/AGALEMED CORPORATIONBYE2026-03-04
00856825003166N/AGALEMED CORPORATIONBYE2026-03-04
00856825003197N/AGALEMED CORPORATIONBYE2026-03-04
00856825003203N/AGALEMED CORPORATIONBYE2026-03-04
00850071887297Emergent RespiratoryMDL Solutions IncorporatedBYE2026-02-11
07045432116083The BAG PEEP Valve 2-10 cmH2OLaerdal Medical ASBYE2026-01-14
07045432116090The BAG PEEP Valve 5-20 cmH2OLaerdal Medical ASBYE2026-01-14
10889483228708WaterPAP™SUNMED, LLCBYE2025-12-15
10889483228715WaterPAP™SUNMED, LLCBYE2025-12-15
10889483270554AirLife™SUNMED, LLCBYE2025-12-15
00810094578541Curaplex®BOUND TREE MEDICAL, LLCBYE2025-08-06
00810094579234Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578558Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094579210Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094579227Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094579272Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
10841470100145O2-MAXPULMODYNE INCBYE2025-04-12
10841470111486Go-PAPPULMODYNE INCBYE2025-04-12
10841470111493Go-PAPPULMODYNE INCBYE2025-04-12
10841470111509Go-PAPPULMODYNE INCBYE2025-04-12
10841470111516Go-PAPPULMODYNE INCBYE2025-04-12
10841470111592Go-PAPPULMODYNE INCBYE2025-04-12
10841470111608Go-PAPPULMODYNE INCBYE2025-04-12
10841470111790Go-PAPPULMODYNE INCBYE2025-04-12
00850071887013Emergent RespiratoryMDL Solutions IncorporatedBYE2025-04-05
00850071887136Emergent RespiratoryMDL Solutions IncorporatedBYE2025-04-05
00850071887174Emergent RespiratoryMDL Solutions IncorporatedBYE2025-04-05
46923980114340N/AGaleMed Xiamen Co., Ltd.BYE2024-09-11
B00500251DMRI0AincAANESTHESIA ASSOCIATES, INC.BYE2024-06-18