FDA.reportPublic FDA data

AirLife™

Primary DI
10889483570944
Brand
AirLife™
Company
AIRLIFE
Model
002060
Catalog number
002060
Device description
Tee Adapter with Valve
Published
2025-02-20
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
BYHDrain, Tee (Water Trap)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYHDrain, Tee (Water Trap)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483570948PackageGS130In Commercial Distribution
10190752131101PreviousGS10
10889483570944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948357094830889483570948
1019075213110110190752131101
1088948357094410889483570944

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic agent nebulizer, benchtopAn assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

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
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10190752119680Vital Signs™A4FX20X4VA4FX20X4V2020-02-20
10190752120013Vital Signs™A4UX204XA4UX204X2019-12-20
10190752120020Vital Signs™A4UX20X4A1A4UX20X4A12019-12-20
10190752120174Vital Signs™A4UX8XXXA4UX8XXX2019-12-20
10190752120747Vital Signs™A5U52X14A5U52X142019-12-20
10190752120914Vital Signs™A5Z1XXXXA5Z1XXXX2019-12-20
10190752121065Vital Signs™A8F11XXXA8F11XXX2020-02-20
10190752121072Vital Signs™A8FX804XA8FX804X2019-12-20
10190752121096Vital Signs™A8T52914A8T529142019-12-20
10190752121140Vital Signs™A8U52X14A8U52X142019-12-20
10190752121188Vital Signs™A8UX19XXA8UX19XX2020-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957544Create BiotechCREATE BIOTECH CO., LTD.BYH2026-07-21
04710810084157N/AGALEMED CORPORATIONBYH2026-03-04
04710810119491N/AGALEMED CORPORATIONBYH2026-03-04
04710810119507N/AGALEMED CORPORATIONBYH2026-03-04
04710810119545N/AGALEMED CORPORATIONBYH2026-03-04
04710810119552N/AGALEMED CORPORATIONBYH2026-03-04
04710810119569N/AGALEMED CORPORATIONBYH2026-03-04
04710810119576N/AGALEMED CORPORATIONBYH2026-03-04
24710810084151N/AGALEMED CORPORATIONBYH2026-03-04
44710810119499N/AGALEMED CORPORATIONBYH2026-03-04
44710810119505N/AGALEMED CORPORATIONBYH2026-03-04
44710810119543N/AGALEMED CORPORATIONBYH2026-03-04
44710810119550N/AGALEMED CORPORATIONBYH2026-03-04
44710810119567N/AGALEMED CORPORATIONBYH2026-03-04
44710810119574N/AGALEMED CORPORATIONBYH2026-03-04
10197344011018HUDSON RCIMEDLINE INDUSTRIES, INC.BYH2025-08-18
20197344011015HUDSON RCIMEDLINE INDUSTRIES, INC.BYH2025-08-18
10889483571910AirLife™AIRLIFEBYH2025-03-28
30889483571914AirLife™Sunmed Group Holdings, LLCBYH2025-03-28
10889483570937AirLife™AIRLIFEBYH2025-03-18
10889483570951AirLife™AIRLIFEBYH2025-03-18
30889483570931AirLife™Sunmed Group Holdings, LLCBYH2025-03-18
30889483570955AirLife™Sunmed Group Holdings, LLCBYH2025-03-18
10889483570777AirLife™AIRLIFEBYH2025-02-20
10889483570784AirLife™AIRLIFEBYH2025-02-20
30889483570771AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
30889483570788AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
30889483570948AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
10889483585757AirLife™AIRLIFEBYH2025-02-12
30889483585751AirLife™Sunmed Group Holdings, LLCBYH2025-02-12