FDA.reportPublic FDA data

AirLife™

Primary DI
10889483630457
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
377ASL
Catalog number
377ASL
Device description
AirLife DuoTherm™ Heater Wire Adapter, Reusable, Single Limb
Published
2025-02-21
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
false

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
10889483630457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948363045710889483630457

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2797info@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
false
Serial number
true
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
64897132250476TECMEVINCENT HEALTHCARE PRODUCTS LIMITEDBTT2026-03-17
64897132250315inspired™VINCENT HEALTHCARE PRODUCTS LIMITEDBTT2026-03-05
30889483631472AirLifeSUNMED, LLCBTT2026-02-27
09420012481757F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481801F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481825F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
10197344007165HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-03
20197344005991HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-02
20197344009722HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
10889483648162AirLife™AIRLIFEBTT2026-01-14
20197344009821HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009852HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009869HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009876HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029706HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029713HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029720HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009586HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344009845HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344011022HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344011053HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
54026704734097HUDSON RCITELEFLEX INCORPORATEDBTT2025-06-04
54026704734103HUDSON RCITELEFLEX INCORPORATEDBTT2025-06-04
07321820069774Vivo 1/2, Vivo 3Breas Medical ABBTT2025-05-19
10889483631416AirLife™AIRLIFEBTT2025-04-21
10889483631423AirLife™AIRLIFEBTT2025-04-21
10889483631430AirLife™AIRLIFEBTT2025-04-21
10889483631447AirLife™AIRLIFEBTT2025-04-21
10889483631454AirLife™AIRLIFEBTT2025-04-21
10889483631461AirLife™AIRLIFEBTT2025-04-21