FDA.reportPublic FDA data

AirLife

Primary DI
50885403039803
Brand
AirLife
Company
Carefusion Corporation
Model
7331-HS5
Catalog number
7331-HS5
Device description
Airlife™ Isothermal™ Breathing Circuit Pediatric Inspiratory Line Heated
Published
2016-09-01
Public version status
Update
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
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403039803PackageGS120In Commercial Distribution
10885403039805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540303980350885403039803
1088540303980510885403039805

GMDN Terms#

Term, Definition table
TermDefinition
Benchtop nebulizer, heatedAn assembly of devices intended to be used in the home and clinical settings to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of a benchtop assembly with an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held nebulizing/inhalation compartment (e.g., inflatable balloon with mouthpiece).

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
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
10885403006432AirLife0020060020062016-09-01
10885403011870AirLife9066-HS79066-HS72016-09-01
10885403026799AirLife10808-H1210808-H122016-09-01
10885403026850AirLife1212-H111212-H112016-09-01
10885403026881AirLife1704-H071704-H072016-09-01
10885403026959AirLife5753-H105753-H102016-09-01
10885403027024AirLife6463-H086463-H082016-09-01
10885403027055AirLife6814-H126814-H122016-09-01
10885403027116AirLife7102-HS77102-HS72016-09-01
10885403027130AirLife7104-HS77104-HS72016-09-01
10885403027154AirLife7142-HS77142-HS72016-09-01
10885403027185AirLife7149-HS77149-HS72016-09-01
10885403027260AirLife7418-HS37418-HS32016-09-01
10885403027314AirLife9037-HS79037-HS72016-09-01
10885403027390AirLife9061-HS79061-HS72016-09-01
10885403027420AirLife9064-HS79064-HS72016-09-01
10885403027444AirLife9065-HS79065-HS72016-09-01
10885403027451AirLife9073-HS79073-HS72016-09-01
10885403027581AirLifeRC6Y023034RC6Y0230342016-09-01
10885403027598AirLifeRT409-852RT409-8522016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344039418HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043064HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043071HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043101HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043118HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344176434HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176441HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176458HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176465HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344011629HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-01-21
10889483617007AirLife™AIRLIFEBZE2025-02-27
09420012448422Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012453204Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012459213Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
10197344043040HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043057HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043088HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043095HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
00848530104153Passive Heated Breathing Circuit KitSunset Healthcare Solutions, Inc.BZE2024-05-30
00848530070670Heated CPAP Tube for DreamStation Series and PR System OneSunset Healthcare Solutions, Inc.BZE2024-03-05
00848530102753Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.BZE2024-02-20
04048675389583VentStar humidifier chamber (N)Drägerwerk AG & Co. KGaABZE2023-07-21
04048675411758VentStar Helix heated (N) PlusDrägerwerk AG & Co. KGaABZE2023-07-21
04048675414520Double connector 11ID/15OD 20xDrägerwerk AG & Co. KGaABZE2023-07-21
04048675742739VentStar Helix dual heated N Exten. KitDrägerwerk AG & Co. KGaABZE2023-07-21
09420012431080Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012431165Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012432162Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012456601Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
05404013004560HybernitePlastiflex Group NVBZE2022-07-03