FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956106183
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN56PCC14
Catalog number
SAN56PCC14
Device description
PORTA CATH TRAY
Published
2025-06-11
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
OKEPort introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956106183PackageGS13In Commercial Distribution
10198956106185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895610618350198956106183
1019895610618510198956106185

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
50198956293159CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956420708CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956424478CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956412321CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-19
50198956328134CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-10
50198956322194CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956339741CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956363531CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956401011CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956375688CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956377095CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956398625CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956336023CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359060CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359770CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956380446CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956323030CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956333992CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956344530CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956338096CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-17
50198956323115CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-13
50198956322682CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956333626CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956335200CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956356243CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956341591CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-30
50198956306118CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-23
50198956258585CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-22
00191072241610ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14
00191072241634ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14