FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106347188
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-3766I
Catalog number
03-3766I
Device description
HEMODIALYSIS ON OFF PACK
Published
2023-07-25
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
FKGTRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKGTray, Start/Stop (Including Contents), DialysisGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106347186PackageGS124In Commercial Distribution
10197106347188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710634718650197106347186
1019710634718810197106347188

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. 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
10198956441064CARDINAL HEALTHCardinal Health 200, LLCFKG2026-05-08
10198956094727CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
50198956094725CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
10197106986493CARDINAL HEALTHCardinal Health 200, LLCFKG2025-03-21
50197106986491CARDINAL HEALTHCardinal Health 200, LLCFKG2025-03-21
10653160378686MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-08-05
00653160378689MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-08-05
10653160376583MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-06-26
00653160376586MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-06-26
10653160375173MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
00653160375176MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
10653160373582MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
00653160373585MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
10809160422687Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
20809160422684Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
10653160372400MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
00653160372403MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
10197106349861CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
50197106349869CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
50197106347186CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
10653160361008MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
00653160361001MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
10197106092453CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
50197106092451CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
10653160359630MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
00653160359633MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
10197106230992CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25
50197106230990CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25
10197106200292CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
10197106212653CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18