FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594321114
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT23CPVAD
Catalog number
SOT23CPVAD
Device description
CYSTO PACK
Published
2022-02-01
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
NWAProsthesis, tracheal, preformed/molded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWAProsthesis, Tracheal, Preformed/MoldedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594321114PackageGS13In Commercial Distribution
10195594321116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559432111450195594321114
1019559432111610195594321116

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various sterile urological surgical instruments and the necessary materials intended to be used to perform a urological surgical procedure. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. 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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14063108100921TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100938TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100945TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100952TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100969TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100976TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100983TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100990TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101003TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101010TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101027TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101034TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101041TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101058TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101065TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101072TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101089TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101096TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101270TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101287TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101294TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101300TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101324TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101331TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101348TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101355TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101362TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101942TRACHEOBRONXANE™ DUMON® RADIOPAQUENOVATECHNWA2024-11-22
14063108101959TRACHEOBRONXANE™ DUMON® RADIOPAQUENOVATECHNWA2024-11-22
14063108101966TRACHEOBRONXANE™ DUMON® RADIOPAQUENOVATECHNWA2024-11-22