FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106292073
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-5329H
Catalog number
03-5329H
Device description
DIALYSIS TRAY
Published
2023-06-08
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
PEVDialysis administration kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEVDialysis Administration KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106292073PackageGS130In Commercial Distribution
10197106292075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710629207350197106292073
1019710629207510197106292075

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, single-useA collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. 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
50198956419108CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
20809160508425Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
40198459467609MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
40198459394974MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
40198459337537MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
40198459329402Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
40198459283797Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
40653160998809Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
50197106795673CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
40198459149376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40195327571123Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327594023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327653461Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05
20809160418113Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2024-01-30
40195327538591Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-21
40195327544820Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-21
40653160995778Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2023-12-21
40653160995785Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2023-12-21
40195327572663Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-17
40195327572670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-17
40195327531547Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-10-29
40195327535200Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-10-29
40195327535217Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-10-29
50197106403271CARDINAL HEALTHCardinal Health 200, LLCPEV2023-09-14
40195327429752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-07-29
40195327459223Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-07-23
40195327421916Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-06-25
50197106294916CARDINAL HEALTHCardinal Health 200, LLCPEV2023-06-15
40195327421398Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-06-04