FDA.reportPublic FDA data

AirLife™

Primary DI
10889483571910
Brand
AirLife™
Company
AIRLIFE
Model
008178
Catalog number
008178
Device description
"AirLife™ Trach ""Y"" with Port Bulk Pack"
Published
2025-03-28
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
30889483571914PackageGS1250In Commercial Distribution
10889483571910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948357191430889483571914
1088948357191010889483571910

GMDN Terms#

Term, Definition table
TermDefinition
Y-piece breathing circuit connector, single-use"A connecting device shaped in the form of a ""Y"" or ""T"" and designed to connect compatible components [e.g., the tubing and face mask or an endotracheal (ET) tube] to create a breathing circuit. In order to function this device will be part of a breathing circuit and will typically connect the inspiratory and expiratory sides at the point of entry into the patient. It will typically be used during anaesthesia and/or ventilation and is typically made of light plastic. This is a single-use device."

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
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10889483570944AirLife™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
10840330705100ProCureTwin Med, LLCBYH2024-10-30