FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956359459
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN36PPMHB
Catalog number
SAN36PPMHB
Device description
SMH PICC PACK
Published
2026-02-09
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
PXKVascular access port kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXKVascular Access Port KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956359459PackageGS16In Commercial Distribution
10198956359451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895635945950198956359459
1019895635945110198956359451

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.

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
10198956472419CARDINAL HEALTHCardinal Health 200, LLCPXK2026-05-25
50198956360844CARDINAL HEALTHCardinal Health 200, LLCPXK2026-03-19
50198956334302CARDINAL HEALTHCardinal Health 200, LLCPXK2026-03-16
50198956371345CARDINAL HEALTHCardinal Health 200, LLCPXK2026-03-03
50198956343144CARDINAL HEALTHCardinal Health 200, LLCPXK2026-03-02
50198956371369CARDINAL HEALTHCardinal Health 200, LLCPXK2026-03-02
50198956393651CARDINAL HEALTHCardinal Health 200, LLCPXK2026-03-02
50198956335170CARDINAL HEALTHCardinal Health 200, LLCPXK2026-02-23
50198956244007CARDINAL HEALTHCardinal Health 200, LLCPXK2026-02-09
50198956327960CARDINAL HEALTHCardinal Health 200, LLCPXK2026-02-09
50198956339710CARDINAL HEALTHCardinal Health 200, LLCPXK2026-02-09
50198956340525CARDINAL HEALTHCardinal Health 200, LLCPXK2026-02-09
50198956358216CARDINAL HEALTHCardinal Health 200, LLCPXK2026-02-09
50198956284348CARDINAL HEALTHCardinal Health 200, LLCPXK2026-01-23
50198956294347CARDINAL HEALTHCardinal Health 200, LLCPXK2026-01-23
50198956306835CARDINAL HEALTHCardinal Health 200, LLCPXK2026-01-23
50198956301793CARDINAL HEALTHCardinal Health 200, LLCPXK2026-01-15
50198956315165CARDINAL HEALTHCardinal Health 200, LLCPXK2026-01-05
50198956270679CARDINAL HEALTHCardinal Health 200, LLCPXK2025-12-31
50198956163063CARDINAL HEALTHCardinal Health 200, LLCPXK2025-12-26
50198956308518CARDINAL HEALTHCardinal Health 200, LLCPXK2025-12-26
50198956250183CARDINAL HEALTHCardinal Health 200, LLCPXK2025-12-23
50198956266207CARDINAL HEALTHCardinal Health 200, LLCPXK2025-12-22
50198956261240CARDINAL HEALTHCardinal Health 200, LLCPXK2025-12-17
50198956233421CARDINAL HEALTHCardinal Health 200, LLCPXK2025-12-11
50198956286038CARDINAL HEALTHCardinal Health 200, LLCPXK2025-12-11
50198956236026CARDINAL HEALTHCardinal Health 200, LLCPXK2025-12-09
50198956213676CARDINAL HEALTHCardinal Health 200, LLCPXK2025-11-28
50198956224047CARDINAL HEALTHCardinal Health 200, LLCPXK2025-11-24
50198956180855CARDINAL HEALTHCardinal Health 200, LLCPXK2025-09-29