FDA.reportPublic FDA data

AirLife™

Primary DI
10190752114432
Brand
AirLife™
Company
AIRLIFE
Model
2K8037
Catalog number
2K8037
Device description
"AirLife™ Pediatric Manual Resuscitator; 40""(1.0m) Oxygen Resevoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock"
Published
2019-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFPAnesthesia breathing circuit kit (adult & pediatric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752114430PackageGS16In Commercial Distribution
10190752114432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075211443050190752114430
1019075211443210190752114432

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, reusableA non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1000Milliliter
Weight0.4Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483586358Vital Signs™5503B5503B2025-02-18
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 ml0026200026202025-02-20
10889483617007AirLife™RC6Y023034RC6Y0230342025-02-27
10889483618264Air LifeAM-20002026-08-26
10889483618271Air LifeAM-21002026-08-26
10889483618288Air LifeAM-22002026-08-26
10889483618295Air LifeAM-30002026-08-26
10889483618301Air LifeAM-31002026-08-26
10889483618318Air LifeAM-32002026-08-26
10190752118379Vital Signs™2L39882L39882019-12-20
10190752118430Vital Signs™5030AE5030AE2020-02-20
10190752118973Vital Signs™5236AAE5236AAE2019-12-20
10190752119017Vital Signs™5372AE5372AE2019-12-20
10190752119215Vital Signs™A1UXOXXXA1UXOXXX2019-12-20
10190752119246Vital Signs™A1ZX1XXXA1ZX1XXX2020-02-20
10190752119369Vital Signs™A46517XXA46517XX2019-12-20
10190752119437Vital Signs™A46X8XXXA46X8XXX2019-12-20
10190752119628Vital Signs™A4FX1XXXA4FX1XXX2019-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956484382CARDINAL HEALTHCardinal Health 200, LLCOFP2026-09-25
10680651497571HalyardO&M HALYARD, INC.OFP2026-06-06
10680651497588HalyardO&M HALYARD, INC.OFP2026-06-06
10680651497595HalyardO&M HALYARD, INC.OFP2026-06-06
10198956137240CARDINAL HEALTHCardinal Health 200, LLCOFP2025-08-11
10889483597422Vital Signs™AIRLIFEOFP2025-03-27
10889483592748Vital Signs™AIRLIFEOFP2025-03-07
10889483599969Vital Signs™AIRLIFEOFP2025-03-07
10889483580035AirLife™AIRLIFEOFP2025-02-20
10889483581513AirLife™AIRLIFEOFP2025-02-20
10889483581520AirLife™AIRLIFEOFP2025-02-20
10889483584118AirLife™AIRLIFEOFP2025-02-20
10889483584125AirLife™AIRLIFEOFP2025-02-20
10889483598207Vital Signs™AIRLIFEOFP2025-02-19
10889483592687Vital Signs™AIRLIFEOFP2025-02-18
10889483595145Vital Signs™AIRLIFEOFP2025-02-18
10889483595596Vital Signs™AIRLIFEOFP2025-02-18
10889483595855AirLife™AIRLIFEOFP2025-02-18
10889483595886AirLife™AIRLIFEOFP2025-02-18
10889483595909AirLife™AIRLIFEOFP2025-02-18
10889483597484Vital Signs™AIRLIFEOFP2025-02-18
10889483584330AirLife™AIRLIFEOFP2025-02-17
10889483584354AirLife™AIRLIFEOFP2025-02-17
10889483584361AirLife™AIRLIFEOFP2025-02-17
10889483584378AirLife™AIRLIFEOFP2025-02-17
10889483584385AirLife™AIRLIFEOFP2025-02-17
10889483596456Vital Signs™AIRLIFEOFP2025-02-17
10889483597699Vital Signs™AIRLIFEOFP2025-02-17
10889483600177Vital Signs™AIRLIFEOFP2025-02-17
10889483600320Vital Signs™AIRLIFEOFP2025-02-17