FDA.report

AirLife™

Primary DI
30889483570382
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
001505
Catalog number
001505
Device description
AirLife™ Tee adapter With One Arm 22 mm I.D., One Arm 22 mm O.D., 18 mm I.D. Base with Mouthpiece
Published
2025-02-20
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

Related Records

Contact Domains

Product Codes

CodeName
BZAConnector, Airway (Extension)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483570382PackageGS150In Commercial Distribution
10190752145375PreviousGS10
10889483570388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948357038230889483570382
1019075214537510190752145375
1088948357038810889483570388

GMDN Terms

TermDefinition
Benchtop nebulizer, non-heatedAn assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and 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.

Sterilization Methods

Method

Contacts

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
false
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 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

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16923980103206N/AGaleMed Xiamen Co., Ltd.BZA2026-05-25
20197344009807HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
44710810084858N/AGALEMED CORPORATIONBZA2026-03-05
44710810086548N/AGALEMED CORPORATIONBZA2026-03-05
44710810102453N/AGALEMED CORPORATIONBZA2026-03-05
44710810104037N/AGALEMED CORPORATIONBZA2026-03-05
44710810110731N/AGALEMED CORPORATIONBZA2026-03-05
44710810082601N/AGALEMED CORPORATIONBZA2026-03-04
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44710810087187N/AGALEMED CORPORATIONBZA2026-03-04
44710810104563N/AGALEMED CORPORATIONBZA2026-03-04
44710810107328N/AGALEMED CORPORATIONBZA2026-03-04
44710810111417N/AGALEMED CORPORATIONBZA2026-03-04
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00619498004409HumidAirRESMED PTY LTDBZA2026-02-09
04048675034643Connector M34X1.5, 9/16Drägerwerk AG & Co. KGaABZA2026-02-04
04048675034735Adapter 9/16" to 6mmDrägerwerk AG & Co. KGaABZA2026-02-04
20197344012005HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012463HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012593HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344042323HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
46923980107748N/AGaleMed Xiamen Co., Ltd.BZA2025-12-24
46923980107281N/AGaleMed Xiamen Co., Ltd.BZA2025-12-23
20889483225254AirLife™SUNMED, LLCBZA2025-12-22
20889483225223Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
20889483225278AirLife™SUNMED, LLCBZA2025-12-18