FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439419403
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PEHDTRVCC
Catalog number
PEHDTRVCC
Device description
KIT,ORP TRACHEOSTOMY
Published
2019-04-05
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
50888439419403PackageGS12In Commercial Distribution
10888439419405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843941940350888439419403
1088843941940510888439419405

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 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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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