FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594485108
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN13PTLC2
Catalog number
SAN13PTLC2
Device description
IR PORT TRAY
Published
2022-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50195594485106PackageGS14In Commercial Distribution
10195594485108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559448510650195594485106
1019559448510810195594485108

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

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
10194717120162Regard™ROI CPS, LLCOKE2024-10-08
10194717120094Regard™ROI CPS, LLCOKE2024-10-02
10194717119807Regard™ROI CPS, LLCOKE2024-06-26
10194717119234Regard™ROI CPS, LLCOKE2024-04-12
10194717118336Regard™ROI CPS, LLCOKE2024-01-26
10194717117551Regard™ROI CPS, LLCOKE2023-06-21
10194717116660Regard™ROI CPS, LLCOKE2023-01-13
10195594396510CARDINAL HEALTHCardinal Health 200, LLCOKE2022-04-29
10195594519599CARDINAL HEALTHCardinal Health 200, LLCOKE2022-04-21
10194717115717Regard™ROI CPS, LLCOKE2022-04-14
10195594443092CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-26
10195594463663CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-18
10195594510978CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-07
10195594530761CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-01
10195594385910CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594423025CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594456214CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594508517CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-25
10195594530501CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-25
10195594518288CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-23
10194717114437Regard™ROI CPS, LLCOKE2022-01-13
10195594429225CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-13
10195594499464CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-07
10195594486945CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-04
10195594285456CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-30
10195594496050CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-30
10195594504755CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-28
10195594434274CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-22
10195594493004CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-22
10195594413910CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-16