FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106230992
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT4LDPGR6
Catalog number
SOT4LDPGR6
Device description
DIALYSIS OFF PACK
Published
2023-04-25
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
50197106230990PackageGS116In Commercial Distribution
10197106230992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710623099050197106230990
1019710623099210197106230992

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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
10197106347188CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
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
50197106230990CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25
10197106200292CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
10197106212653CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18