FDA.reportPublic FDA data

AirLife™

Primary DI
10889483595831
Brand
AirLife™
Company
AIRLIFE
Model
AH115-05E
Catalog number
AH115-05E
Device description
AirLife DuoTherm® Pressure Relief Valve, 40 cm H2O
Published
2025-02-21
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
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483595835PackageGS15In Commercial Distribution
10889483595831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948359583530889483595835
1088948359583110889483595831

GMDN Terms#

Term, Definition table
TermDefinition
Pressure relief valve, single-useA non-sterile device used to regulate the maximum pressure level in a circuit or system (typically containing gas) where it is essential not to exceed a pre-set maximum pressure. Should this pressure level be exceeded, this device will automatically open and vent the excess pressure from the circuit/system ensuring that an excessive pressure level is not sustained, thereby preventing damage to the patient or a parent device. It is typically used in anaesthesia machines and ventilators forming part of the breathing/gas delivery circuit/system, but may be applied to other functions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2797info@sun-med.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483586358Vital Signs™5503B5503B2025-02-18
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
10889483617007AirLife™RC6Y023034RC6Y0230342025-02-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10197344016884HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
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10197344016938HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016945HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016969HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
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10197344016983HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
00841737100775Vapotherm Inc.VAPOTHERM, INC.BTT2026-06-23
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09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
00810083350561SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
10889483570906AirLife™AIRLIFEBTT2025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief ValveAIRLIFEBTT2025-02-20
10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 mlAIRLIFEBTT2025-02-20
10197344009749HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-10-31
10197344009756HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-09-24
07640140860749Monsoon III Laserjet 70Acutronic Medical Systems AGBTT2023-01-20
00810071637285CuraplexBOUND TREE MEDICAL, LLCBTT2022-12-30
00810071637292CuraplexBOUND TREE MEDICAL, LLCBTT2022-12-30
00810071637308CuraplexBOUND TREE MEDICAL, LLCBTT2022-12-30
09420012416179Fisher and Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012428493F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429117F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429155F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
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