FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106898152
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SENDHTPPCE
Catalog number
SENDHTPPCE
Device description
TRACHEOSTOMY EHMC PACK
Published
2025-06-16
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
50197106898152PackageGS12In Commercial Distribution
10197106898154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710689815250197106898152
1019710689815410197106898154

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, medicatedA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform an ENT surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
10198956075962CARDINAL HEALTHCardinal Health 200, LLCOGW2025-06-10