FDA.reportPublic FDA data

AirLife™

Primary DI
10889483229422
Brand
AirLife™
Company
SUNMED, LLC
Model
0485
Catalog number
0485
Device description
"AirLife™ Concentrator Humidifier Adapter, 15"" O Tubing with Threaded Nut Connector"
Published
2025-12-19
Public version status
New
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
KFZHumidifier, Non-Direct Patient Interface (Home-Use)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFZHumidifier, Non-Direct Patient Interface (Home-Use)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483229429PackageGS150In Commercial Distribution
00709078003868PreviousGS10
10889483229422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088948322942920889483229429
00709078003868007090780038687090780038680709078003868
1088948322942210889483229422

GMDN Terms#

Term, Definition table
TermDefinition
Non-heated respiratory humidifierA 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. This device, commonly known as a bubble humidifier, 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
1-800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483155912SunMed4-0050-10M4-0050-10M2023-07-18
10889483225448Septal-H™CP-5410CP-54102025-12-15
10889483225455Septal-H™CP-5500CP-55002025-12-15
10889483230244AirLife™TC-1022TC-10222025-12-15
10889483033289SunMed9-0210-019-0210-012024-03-12
10889483564578BALLARD™221036-5227036-52025-11-21
10889483040218SunMed5-0236-315-0236-312023-03-21
10889483221150AirLife™093709372025-12-18
10889483221181Vital Signs™8809-W8809-W2025-12-23
10889483221747AirLife™026202622025-12-19
10889483222027Co2 Easy5621342026-03-31
10889483222034Pedi Co2 Easy5621352026-03-31
10889483222157Ambu900-000-601900-000-6012025-12-19
10889483222164Ambu900-000-602900-000-6022025-12-19
10889483222188Ambu900-000-604900-000-6042025-12-19
10889483222195Ambu900-000-605900-000-6052025-12-19
10889483222201Ambu900-000-606900-000-6062025-12-19
10889483222225Ambu900-000-609900-000-6092025-12-19
10889483222232Ambu900-000-611900-000-6112025-12-19
10889483222393AirLife™056205622025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194346604845EquateWAL-MART STORES, INC.KFZ2026-02-16
00328785008234HONEYWELLKAZ USA, INC.KFZ2026-02-04
00328785008258HoneywellKAZ USA, INC.KFZ2026-02-04
00328785012828VicksKAZ USA, INC.KFZ2026-02-04
00328785101539VicksKAZ USA, INC.KFZ2026-02-04
00328785002263HoneywellKAZ USA, INC.KFZ2026-02-04
10328785008231HONEYWELLKAZ USA, INC.KFZ2026-02-04
10328785008255HoneywellKAZ USA, INC.KFZ2026-02-04
00328785012804VicksKAZ USA, INC.KFZ2026-02-04
00328785012811VicksKAZ USA, INC.KFZ2026-02-04
10328785012825VicksKAZ USA, INC.KFZ2026-02-04
00328785012835VicksKAZ USA, INC.KFZ2026-02-04
10328785101536VicksKAZ USA, INC.KFZ2026-02-04
00328785008241HONEYWELLKAZ USA, INC.KFZ2026-02-03
00050428005583CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-28
00328785009620VICKSKAZ USA, INC.KFZ2026-01-28
00328785013863VicksKAZ USA, INC.KFZ2026-01-28
00328785014426VicksKAZ USA, INC.KFZ2026-01-28
00050428005606CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-26
10050428005603CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-26
00050428005613CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-23
10050428005610CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-23
10889483054338AirLife™SUNMED, LLCKFZ2025-12-19
20889483054335AirLife™SUNMED, LLCKFZ2025-12-19
20889483229429AirLife™SUNMED, LLCKFZ2025-12-19
10889483054321AirLife™SUNMED, LLCKFZ2025-12-18
20889483054328AirLife™SUNMED, LLCKFZ2025-12-18
00328785002454VicksKAZ, INC.KFZ2025-05-05
00328785002478VicksKAZ, INC.KFZ2025-05-05
00851440007704Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.KFZ2024-08-01