FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439260847
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN73AACHC
Catalog number
SEN73AACHC
Device description
AIRWAY CUSTOM PK
Published
2018-11-20
Public version status
Update
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
50888439260845PackageGS17In Commercial Distribution
10888439260847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843926084550888439260845
1088843926084710888439260847

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.

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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
10197106539682CARDINAL HEALTHCardinal Health 200, LLCOFO2024-01-23
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