FDA.reportPublic FDA data

Vital Signs™

Primary DI
10889483595930
Brand
Vital Signs™
Company
AIRLIFE
Model
AHAX8XX4
Catalog number
AHAX8XX4
Device description
Vital Signs™ Adult Anesthesia Breathing Circuit
Published
2025-02-14
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
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483595934PackageGS120In Commercial Distribution
10190752122840PreviousGS10
10889483595930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948359593430889483595934
1019075212284010190752122840
1088948359593010889483595930

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory line humidification chamber, single-useA device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a plastic chamber intended to allow the water to be heated by the attached humidifier and the subsequent vapour to be delivered to the patient through a connected breathing circuit. It may be used in a healthcare setting or in the home. 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
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645010048Standard Breathing Circuit with Face Mask - ToddlerMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010079Standard Breathing Circuit with MouthpieceMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010116Standard Breathing Circuit with Face Mask - Adult MediumMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010550Standard Breathing Circuit with TrachMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
H66860701051Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
H66860701151Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
10080196082070Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983599Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983933Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983940Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983971Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196984176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
10080196984343Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
10190752108806Vital Signs™AirLife Finland OyCAI2021-07-06
10190752108820Vital Signs™VYAIRE MEDICAL, INC.CAI2021-07-06
10190752118416Vital Signs™AIRLIFECAI2020-02-20
10190752118430Vital Signs™AIRLIFECAI2020-02-20
10190752118485Vital Signs™AIRLIFECAI2020-02-20
10190752118843Vital Signs™AIRLIFECAI2020-02-20
10190752118850Vital Signs™AIRLIFECAI2020-02-20
10190752118867Vital Signs™AIRLIFECAI2020-02-20
10190752118874Vital Signs™AIRLIFECAI2020-02-20
10190752118881Vital Signs™AIRLIFECAI2020-02-20
10190752118898Vital Signs™AIRLIFECAI2020-02-20
10190752118904Vital Signs™AIRLIFECAI2020-02-20
10190752118911Vital Signs™AIRLIFECAI2020-02-20
10190752118928Vital Signs™AIRLIFECAI2020-02-20
10190752118942Vital Signs™AIRLIFECAI2020-02-20
10190752118997Vital Signs™VYAIRE MEDICAL, INC.CAI2020-02-20