FDA.reportPublic FDA data

Dover

Primary DI
10192253068559
Brand
Dover
Company
Cardinal Health 200, LLC
Model
3141
Catalog number
3141
Device description
OPEN URETHRAL TRAY, VINYL CATHETER, 1000 ML BASIN, PVP, PREPPING COMPONENTS, 14 FR (4.7 MM)
Published
2026-01-16
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
FCMTray, catheterization, sterile urethral, with or without catheter (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253068557PackageGS120In Commercial Distribution
10192253068559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306855750192253068557
1019225306855910192253068559

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071078DoverCardinal Health 200, LLCFCM2026-06-24
10192253071115DoverCardinal Health 200, LLCFCM2026-06-24
10192253071122DoverCardinal Health 200, LLCFCM2026-06-24
14026704945990RUSCHTELEFLEX INCORPORATEDFCM2026-05-12
10192253069549DoverCardinal Health 200, LLCFCM2026-01-20
10192253068535DoverCardinal Health 200, LLCFCM2026-01-16
10192253068542DoverCardinal Health 200, LLCFCM2026-01-16
10192253068566DoverCardinal Health 200, LLCFCM2026-01-16
10192253068573DoverCardinal Health 200, LLCFCM2026-01-16
10192253068580DoverCardinal Health 200, LLCFCM2026-01-16
10192253068597DoverCardinal Health 200, LLCFCM2026-01-16
10192253068610DoverCardinal Health 200, LLCFCM2026-01-16
10192253068665DoverCardinal Health 200, LLCFCM2026-01-16
10192253068702DoverCardinal Health 200, LLCFCM2026-01-16
10192253067958DoverCardinal Health 200, LLCFCM2026-01-15
10192253067996DoverCardinal Health 200, LLCFCM2026-01-15
10192253068009DoverCardinal Health 200, LLCFCM2026-01-15
10192253070859DoverCardinal Health 200, LLCFCM2026-01-15
10192253027754DoverCardinal Health 200, LLCFCM2025-12-10
10192253028836DoverCardinal Health 200, LLCFCM2025-12-10
10192253028843DoverCardinal Health 200, LLCFCM2025-12-10
10192253030174DoverCardinal Health 200, LLCFCM2025-10-17
10192253028935DoverCardinal Health 200, LLCFCM2025-09-16
10192253028942DoverCardinal Health 200, LLCFCM2025-09-16
10704411019541AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019558AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019565AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019572AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019589AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019596AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01