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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

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