FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488100654
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN73AACHB
Catalog number
SEN73AACHB
Device description
AIRWAY CUSTOM PK
Published
2016-08-10
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
50887488100652PackageGS17In Commercial Distribution
10887488100654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748810065250887488100652
1088748810065410887488100654

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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

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