FDA.reportPublic FDA data

AirLife

Primary DI
50885403296343
Brand
AirLife
Company
Carefusion Corporation
Model
9003B
Catalog number
9003B
Device description
AirLife® bi-directional flow guard PEEP valve
Published
2016-09-01
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
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
50885403296343PackageGS110Not in Commercial Distribution
10885403296345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540329634350885403296343
1088540329634510885403296345

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(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
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