FDA.reportPublic FDA data

AirLife™

Primary DI
30889483595910
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
AH280
Catalog number
AH280
Device description
AirLife™ Adult Heated Wire Circuit Kit Dual-limb, Dual-heated circuit, Contains AH180 circuit, AH290 Chamber
Published
2025-02-18
Public version status
New
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
OGLOxygen Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGLOxygen Administration KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483595910PackageGS110In Commercial Distribution
10190752145177PreviousGS10
10889483595916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948359591030889483595910
1019075214517710190752145177
1088948359591610889483595916

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
119058668
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
30889483569522AirLife™001248U001248U2025-03-28
30889483570566AirLife™0018000018002025-03-28
30889483571914AirLife™0081780081782025-03-28
30889483570474AirLife™0016080016082025-03-27
30889483570559AirLife™0017970017972025-03-27
30889483570573AirLife™0018010018012025-03-27
30889483570597AirLife™0018030018032025-03-27
30889483570603AirLife™0018100018102025-03-27
30889483570658AirLife™0018220018222025-03-27
30889483570665AirLife™0018230018232025-03-27
30889483570672AirLife™0018240018242025-03-27
30889483570689AirLife™0018300018302025-03-27
30889483570863AirLife™0019510019512025-03-27
30889483570887AirLife™0019550019552025-03-27
30889483571679AirLife™0037600037602025-03-27
30889483571686AirLife™0037620037622025-03-27
30889483571693AirLife™0037640037642025-03-27
30889483572119AirLife™0P17750P17752025-03-27
30889483572126AirLife™0P17760P17762025-03-27
30889483572164AirLife™0Y37700Y37702025-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109905Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-09-30
00848530109523Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-08-20
00848530109295Oxygen kitSunset Healthcare Solutions, Inc.OGL2026-06-11
00848530104443Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530104450Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530105402Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530108915Repair PartsSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530108922Repair PartsSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530108908Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-20
00848530108595Repair PartsSunset Healthcare Solutions, Inc.OGL2026-04-13
00848530108601Repair LabelSunset Healthcare Solutions, Inc.OGL2026-04-13
00848530108526Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-07
00848530108533Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-07
00848530108625Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-07
00848530108762Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-07
00848530108649Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-17
00848530108663Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-17
00848530108687Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-17
10848530108646Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108660Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108684Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108571Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-09
00848530108588Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-09
00848530108434Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-02-18
00848530108311Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-02-11
00848530108304Repair PartsSunset Healthcare Solutions, Inc.OGL2026-01-26
00848530108229REPAIR PARTSunset Healthcare Solutions, Inc.OGL2026-01-19
00848530108243REPAIR PARTSunset Healthcare Solutions, Inc.OGL2026-01-19
00848530108250REPAIR PARTSunset Healthcare Solutions, Inc.OGL2026-01-19
10848530108226REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19