FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439921739
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03B0368
Catalog number
03B0368
Device description
PORTACATH TRAY
Published
2020-10-30
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
50888439921739PackageGS130In Commercial Distribution
10888439921731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843992173950888439921739
1088843992173110888439921731

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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
20885380214377KendallCB2LCB2L2026-10-12
20885380214384KendallCB2LITECB2LITE2026-10-12
20885380214391KendallCB2XLCB2XL2026-10-12
20885380214407KendallCB3LCB3L2026-10-12
20885380214414KendallCB4LCB4L2026-10-12
10192253046397Kendall55535PAMD55535PAMD2023-09-27
10192253046762Kendall55588BAMD55588BAMD2023-10-09
10885380173691Curity6309G6309G2019-11-14
20192253039358Kerlix458845882025-03-19
20192253039365Kerlix50425042-2025-03-19
20192253039372Kerlix61206120-2025-03-19
20192253039396Kerlix507250722025-03-19
20192253039594Kerlix258525852025-03-19
20885380173490Curity2556G2556G2019-11-14
20885380173513Curity2835G2835G2019-11-14
20192253008347CARDINAL HEALTH5005005005002020-09-24
20192253016632Kendall222002A222002A-2024-02-28
20192253016830Kendall30710001307100012024-02-28
20192253017813KendallEF00149EF001492024-02-28
20885380130950MEDI-VAC65652-11965652-1192018-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956598102CARDINAL HEALTHCardinal Health 200, LLCOKE2026-10-12
10198956598409CARDINAL HEALTHCardinal Health 200, LLCOKE2026-10-12
10198956599482CARDINAL HEALTHCardinal Health 200, LLCOKE2026-10-12
10198956604315CARDINAL HEALTHCardinal Health 200, LLCOKE2026-10-12
10198956601963CARDINAL HEALTHCardinal Health 200, LLCOKE2026-10-06
10198956587557CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-29
00849884007824VYGONVygon CorporationOKE2026-09-25
10198956578548CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-25
10198956539907CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-04
10198956569287CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-04
10198956572973CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-04
10198956552678CARDINAL HEALTHCardinal Health 200, LLCOKE2026-08-26
00199972000528CuraplexBOUND TREE MEDICAL, LLCOKE2026-08-15
10198956519633CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-27
10198956530409CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-27
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