FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106273188
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SENDHTPPCC
Catalog number
SENDHTPPCC
Device description
TRACHEOSTOMY PACK
Published
2023-07-24
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
50197106273188PackageGS12In Commercial Distribution
10197106273180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710627318850197106273188
1019710627318010197106273180

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956395808CARDINAL HEALTHCardinal Health 200, LLCOGW2026-03-02
50198956396263CARDINAL HEALTHCardinal Health 200, LLCOGW2026-03-02
50198956280364CARDINAL HEALTHCardinal Health 200, LLCOGW2026-01-22
50198956291490CARDINAL HEALTHCardinal Health 200, LLCOGW2026-01-05
50198956277128CARDINAL HEALTHCardinal Health 200, LLCOGW2025-12-17
50198956251647CARDINAL HEALTHCardinal Health 200, LLCOGW2025-11-17
50197106893157CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-22
50198956152920CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-07
50198956164091CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-06
50197106898152CARDINAL HEALTHCardinal Health 200, LLCOGW2025-06-16
50198956075960CARDINAL HEALTHCardinal Health 200, LLCOGW2025-06-10
10661392008042LSL HEALTHCARELSL Industries, LLCOGW2025-05-16
50198956082203CARDINAL HEALTHCardinal Health 200, LLCOGW2025-05-15
50198956068993CARDINAL HEALTHCardinal Health 200, LLCOGW2025-05-07
10661392006406LSL HEALTHCARELSL Industries, LLCOGW2025-04-22
50198956027440CARDINAL HEALTHCardinal Health 200, LLCOGW2025-04-08
50198956013924CARDINAL HEALTHCardinal Health 200, LLCOGW2025-03-31
50198956008951CARDINAL HEALTHCardinal Health 200, LLCOGW2025-03-25
50197106986293CARDINAL HEALTHCardinal Health 200, LLCOGW2025-03-11
50197106789467CARDINAL HEALTHCardinal Health 200, LLCOGW2025-02-10
50197106922567CARDINAL HEALTHCardinal Health 200, LLCOGW2025-01-28
50197106888962CARDINAL HEALTHCardinal Health 200, LLCOGW2024-12-31
50197106729043CARDINAL HEALTHCardinal Health 200, LLCOGW2024-10-09
50197106786077CARDINAL HEALTHCardinal Health 200, LLCOGW2024-09-26
50197106760237CARDINAL HEALTHCardinal Health 200, LLCOGW2024-09-09
50197106593927CARDINAL HEALTHCardinal Health 200, LLCOGW2024-08-23
50197106652228CARDINAL HEALTHCardinal Health 200, LLCOGW2024-07-10
50197106715992CARDINAL HEALTHCardinal Health 200, LLCOGW2024-07-08
50197106667871CARDINAL HEALTHCardinal Health 200, LLCOGW2024-05-23
50197106631582CARDINAL HEALTHCardinal Health 200, LLCOGW2024-05-22