FDA.reportPublic FDA data

AirLife™

Primary DI
10889483572283
Brand
AirLife™
Company
AIRLIFE
Model
1006-H05
Catalog number
1006-H05
Device description
Isothermal Breathing Circuit Adult Inspiratory Line Heated
Published
2025-02-17
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
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
30889483572287PackageGS120In Commercial Distribution
10190752156746PreviousGS10
10889483572283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948357228730889483572287
1019075215674610190752156746
1088948357228310889483572283

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10190752119680Vital Signs™A4FX20X4VA4FX20X4V2020-02-20
10190752120013Vital Signs™A4UX204XA4UX204X2019-12-20
10190752120020Vital Signs™A4UX20X4A1A4UX20X4A12019-12-20
10190752120174Vital Signs™A4UX8XXXA4UX8XXX2019-12-20
10190752120747Vital Signs™A5U52X14A5U52X142019-12-20
10190752120914Vital Signs™A5Z1XXXXA5Z1XXXX2019-12-20
10190752121065Vital Signs™A8F11XXXA8F11XXX2020-02-20
10190752121072Vital Signs™A8FX804XA8FX804X2019-12-20
10190752121096Vital Signs™A8T52914A8T529142019-12-20
10190752121140Vital Signs™A8U52X14A8U52X142019-12-20
10190752121188Vital Signs™A8UX19XXA8UX19XX2020-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10889483572122AirLife™AIRLIFEBZE2025-03-27
10889483572658AirLife™AIRLIFEBZE2025-03-05
10889483572900AirLife™AIRLIFEBZE2025-02-27
10889483572672AirLife™AIRLIFEBZE2025-02-17
10889483572528AirLife™AIRLIFEBZE2025-02-12
10889483572559AirLife™AIRLIFEBZE2025-02-12
10889483572610AirLife™AIRLIFEBZE2025-02-12
10889483572689AirLife™AIRLIFEBZE2025-02-12
10889483572818AirLife™AIRLIFEBZE2025-02-12
10889483572825AirLife™AIRLIFEBZE2025-02-12
10889483572870AirLife™AIRLIFEBZE2025-02-12
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
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
10190752147713AirLife™AIRLIFEBZE2021-05-07
10190752152939AirLife™AIRLIFEBZE2021-05-07
10190752152946AirLife™AIRLIFEBZE2021-05-07