FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594025951
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
15-9801A
Catalog number
15-9801A
Device description
TRACHEOSTOMY TRAY
Published
2021-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGWTracheostomy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGWTracheostomy KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594025951PackageGS130In Commercial Distribution
10195594025953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559402595150195594025951
1019559402595310195594025953

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy kit, single-useA collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10198956468283CARDINAL HEALTHCardinal Health 200, LLCOGW2026-05-19
10198956421844CARDINAL HEALTHCardinal Health 200, LLCOGW2026-05-08
10198956021952CARDINAL HEALTHCardinal Health 200, LLCOGW2026-04-27
10198956377608CARDINAL HEALTHCardinal Health 200, LLCOGW2026-04-21
10198956441279CARDINAL HEALTHCardinal Health 200, LLCOGW2026-04-21
10198956395800CARDINAL HEALTHCardinal Health 200, LLCOGW2026-03-02
10198956396265CARDINAL HEALTHCardinal Health 200, LLCOGW2026-03-02
50198956395808CARDINAL HEALTHCardinal Health 200, LLCOGW2026-03-02
50198956396263CARDINAL HEALTHCardinal Health 200, LLCOGW2026-03-02
10198956280366CARDINAL HEALTHCardinal Health 200, LLCOGW2026-01-22
50198956280364CARDINAL HEALTHCardinal Health 200, LLCOGW2026-01-22
10198956268753CARDINAL HEALTHCardinal Health 200, LLCOGW2026-01-12
10198956291492CARDINAL HEALTHCardinal Health 200, LLCOGW2026-01-05
50198956291490CARDINAL HEALTHCardinal Health 200, LLCOGW2026-01-05
10198956277120CARDINAL HEALTHCardinal Health 200, LLCOGW2025-12-17
50198956277128CARDINAL HEALTHCardinal Health 200, LLCOGW2025-12-17
10198956251649CARDINAL HEALTHCardinal Health 200, LLCOGW2025-11-17
50198956251647CARDINAL HEALTHCardinal Health 200, LLCOGW2025-11-17
10198956249752CARDINAL HEALTHCardinal Health 200, LLCOGW2025-11-04
10198956251410CARDINAL HEALTHCardinal Health 200, LLCOGW2025-10-31
10198956223004CARDINAL HEALTHCardinal Health 200, LLCOGW2025-10-16
10198956203228CARDINAL HEALTHCardinal Health 200, LLCOGW2025-10-06
10197106893159CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-22
50197106893157CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-22
10198956152922CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-07
50198956152920CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-07
10198956164093CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-06
50198956164091CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-06
10197106898154CARDINAL HEALTHCardinal Health 200, LLCOGW2025-06-16
50197106898152CARDINAL HEALTHCardinal Health 200, LLCOGW2025-06-16