FDA.reportPublic FDA data

AirLife™

Primary DI
10889483617007
Brand
AirLife™
Company
AIRLIFE
Model
RC6Y023034
Catalog number
RC6Y023034
Device description
AirLife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit MR850 Heated
Published
2025-02-27
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
10889483617007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948361700710889483617007

GMDN Terms#

Term, Definition table
TermDefinition
Non-heated respiratory humidifier, reusableA non-powered device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (reservoir) for the water, a top piece that functions as a detachable lid (typically a screw lid with a gastight seal), and a tube that protrudes into the water to divert the gas below the water level. Commonly known as a bubble humidifier, it does not heat the water. It has connectors: 1) one (e.g., a winged nut) that connects to an oxygen therapy flowmeter; and 2) one to which the patient tubing is connected. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
119058668
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
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
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
10190752119680Vital Signs™A4FX20X4VA4FX20X4V2020-02-20
10190752120013Vital Signs™A4UX204XA4UX204X2019-12-20

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
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
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
10190752147713AirLife™AIRLIFEBZE2021-05-07
10190752152939AirLife™AIRLIFEBZE2021-05-07
10190752152946AirLife™AIRLIFEBZE2021-05-07
10190752152953AirLife™AIRLIFEBZE2021-05-07
10190752153011AirLife™AIRLIFEBZE2021-05-07
10190752154520AirLife™AIRLIFEBZE2021-05-07
10190752153073AirLife™AIRLIFEBZE2021-04-09
10190752153103AirLife™AIRLIFEBZE2021-04-09
10190752153127AirLife™AIRLIFEBZE2021-04-09