FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106539682
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN73AACHD
Catalog number
SEN73AACHD
Device description
AIRWAY PACK
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFOAirway suction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFOAirway Suction KitAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106539680PackageGS15In Commercial Distribution
10197106539682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710653968050197106539680
1019710653968210197106539682

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956226302CARDINAL HEALTHCardinal Health 200, LLCOFO2025-10-13
10889483601198AirLife™AIRLIFEOFO2025-02-19
10889483601204AirLife™AIRLIFEOFO2025-02-19
30889483601192AirLife™Sunmed Group Holdings, LLCOFO2025-02-19
30889483601208AirLife™Sunmed Group Holdings, LLCOFO2025-02-19
10889483584149AirLife™AIRLIFEOFO2025-02-17
10889483584156AirLife™AIRLIFEOFO2025-02-17
10889483584187AirLife™AIRLIFEOFO2025-02-17
10889483584422AirLife™AIRLIFEOFO2025-02-17
10889483584477AirLife™AIRLIFEOFO2025-02-17
30889483584143AirLife™Sunmed Group Holdings, LLCOFO2025-02-17
30889483584150AirLife™Sunmed Group Holdings, LLCOFO2025-02-17
30889483584181AirLife™Sunmed Group Holdings, LLCOFO2025-02-17
30889483584426AirLife™Sunmed Group Holdings, LLCOFO2025-02-17
30889483584471AirLife™Sunmed Group Holdings, LLCOFO2025-02-17
10889483584439AirLife™AIRLIFEOFO2025-02-14
10889483584460AirLife™AIRLIFEOFO2025-02-14
30889483584433AirLife™Sunmed Group Holdings, LLCOFO2025-02-14
30889483584464AirLife™Sunmed Group Holdings, LLCOFO2025-02-14
50197106539680CARDINAL HEALTHCardinal Health 200, LLCOFO2024-01-23
10190752117686AirLife™AIRLIFEOFO2022-09-05
10190752117693AirLife™AIRLIFEOFO2022-09-05
50190752117684AirLife™VYAIRE MEDICAL, INC.OFO2022-09-05
50190752117691AirLife™VYAIRE MEDICAL, INC.OFO2022-09-05
10190752148901AirLife™AIRLIFEOFO2022-08-22
10190752148956AirLife™AIRLIFEOFO2022-08-22
10190752148963AirLife™AIRLIFEOFO2022-08-22
10190752148994AirLife™AIRLIFEOFO2022-08-22
10190752152045AirLife™AIRLIFEOFO2022-08-22
10190752152052AirLife™AIRLIFEOFO2022-08-22