FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106974049
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN13PTL15
Catalog number
SAN13PTL15
Device description
IR PORT TRAY
Published
2025-03-06
Public version status
New
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
50197106974047PackageGS14In Commercial Distribution
10197106974049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710697404750197106974047
1019710697404910197106974049

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956524644CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-20
10198956504141CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-09
10198956527980CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-09
10198956468474CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-23
10198956421448CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-08
10198956464070CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-05
10198956492936CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-05
10198956320161CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-01
10198956381469CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-01
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
10194717115717Regard™ROI CPS, LLCOKE2022-04-14
10195594443092CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-26
10195594463663CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-18
10195594385910CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594423025CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594456214CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10194717114437Regard™ROI CPS, LLCOKE2022-01-13
10195594429225CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-13
10195594485108CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-13
10195594486945CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-04
10195594285456CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-30
10195594434274CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-22
10195594413910CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-16