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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

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