FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106174294
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-3766G
Catalog number
03-3766G
Device description
HEMODIALYSIS ON OFF PACK
Published
2023-03-29
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
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
50197106174294PackageGS124In Commercial Distribution
10197106174296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710617429450197106174294
1019710617429610197106174296

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

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
50198956094725CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
50197106986491CARDINAL HEALTHCardinal Health 200, LLCFKG2025-03-21
00653160378689MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-08-05
00653160376586MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-06-26
00653160375176MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
00653160373585MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
20809160422684Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
00653160372403MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
50197106349869CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
50197106347186CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
00653160361001MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
50197106092451CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
00653160359633MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
50197106230990CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25
50197106200290CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
50197106212651CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
00653160359541CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2023-04-14
50197106198429CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-30
50197106156009CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-03
50197106136537CARDINAL HEALTHCardinal Health 200, LLCFKG2023-02-23
50197106043323CARDINAL HEALTHCardinal Health 200, LLCFKG2022-12-05
00653160356076CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2022-11-15
00653160356816MEDLINEMEDLINE INDUSTRIES, INC.FKG2022-11-15
00653160356267CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2022-11-08
50195594678768CARDINAL HEALTHCardinal Health 200, LLCFKG2022-10-11
50195594780577CARDINAL HEALTHCardinal Health 200, LLCFKG2022-08-19
50195594756831CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
50195594758521CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
50195594767189CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
00653160353785MEDLINEMEDLINE INDUSTRIES, INC.FKG2022-07-01