FDA.reportPublic FDA data

AirLife

Primary DI
50885403170384
Brand
AirLife
Company
Carefusion Corporation
Model
001800
Catalog number
001800
Device description
AirLife One-Way Valve
Published
2016-08-29
Public version status
Update
Distribution status
Not 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
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403170384PackageGS150Not in Commercial Distribution
10885403170386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540317038450885403170384
1088540317038610885403170386

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.323.9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
830432451
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752101876TiaraTMS-2820912016-09-13
10190752101883TiaraTMS-2821912016-09-13
10190752101890TiaraTMS-2830912016-09-13
10190752101913TiaraTMS-2831912016-09-13
10190752101920TiaraTMS-2840912016-09-13
10190752101944TiaraTMS-2841912016-09-13
10190752101951TiaraTMS-2850912016-09-13
10190752101975TiaraTMS-2851912016-09-13
10190752102033TiaraTMS-12032016-09-13
10190752102040TiaraTMS-1203782016-09-13
10190752102057TiaraTMS-12532016-09-13
10190752102064TiaraTMS-1253782016-09-13
10190752102071TiaraTMS-14032016-09-13
10190752102088TiaraTMS-1403782016-09-13
10190752102095TiaraTMS-25202016-09-13
10190752102101TiaraTMS-25402016-09-13
10190752102118TiaraTMS-2540782016-09-13
10190752102125TiaraTMS-28202016-09-13
10190752102132TiaraTMS-28302016-09-13
10190752102149TiaraTMS-28402016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B448FS1040Seal QuikFirstar Healthcare Company Limited (Guangzhou)CBP2025-12-10
16946430423013Lightning X Products, IncXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2025-06-14
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEIntersurgical IncorporatedCBP2025-04-15
30889483570566AirLife™Sunmed Group Holdings, LLCCBP2025-03-28
16946430421941MENDYOUMEDICALXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2024-11-26
00850055775022BIG EASY, NON-REBREATHING VALVEINNOVATION INSTITUTE, LLCCBP2024-10-30
0503026704086522MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6MIntersurgical IncorporatedCBP2024-09-16
09420012480149Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2024-09-11
04719871890011WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890028WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890042WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890059WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890066ARCFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890073WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890080FukuokaFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890097WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890103WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890110LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890608WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890615MEDSTORMFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890622LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890639WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890646WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890653SoutheasternFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890677FirehouseFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890691FOREMOUNTFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890707WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890714Top SafetyFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890721Top SafetyFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890738WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28