FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956467248
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-5329M
Catalog number
03-5329M
Device description
DIALYSIS TRAY
Published
2026-07-20
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
50198956467246PackageGS130In Commercial Distribution
10198956467248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895646724650198956467246
1019895646724810198956467248

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 Temperature00

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
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
10809160520291Clear SequenceMEDICAL ACTION INDUSTRIES INC.PEV2026-04-28
10198956419100CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
50198956419108CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
10809160508428Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
20809160508425Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
10198459467608MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
40198459467609MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
10198459394973MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
40198459394974MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
10198459337536MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
40198459337537MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
10198459329401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
40198459329402Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
10198459283796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
40198459283797Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
10653160998808Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
40653160998809Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
10197106795675CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
50197106795673CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
10198459149375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
10198459149382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
10195327571122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
10195327594022Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327571123Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327594023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
10195327653460Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05
40195327653461Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05
10197106506998CARDINAL HEALTHCardinal Health 200, LLCPEV2024-02-13