FDA.reportPublic FDA data

Dover

Primary DI
50192253028841
Brand
Dover
Company
Cardinal Health 200, LLC
Model
75005
Catalog number
75005
Device description
DOVER OPEN URETHRAL TRAY, WITH RED RUBBER CATHETER, PREPPING COMPONENTS, 14 FR/CH (4.7 MM)
Published
2025-12-10
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
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
50192253028841PackageGS120In Commercial Distribution
10192253028843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302884150192253028841
1019225302884310192253028843

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
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
05708932778268SpeediCath Flex SetColoplast A/SFCM2026-02-05
50192253069547DoverCardinal Health 200, LLCFCM2026-01-20
50192253068533DoverCardinal Health 200, LLCFCM2026-01-16
50192253068540DoverCardinal Health 200, LLCFCM2026-01-16
50192253068557DoverCardinal Health 200, LLCFCM2026-01-16
50192253068564DoverCardinal Health 200, LLCFCM2026-01-16
50192253068571DoverCardinal Health 200, LLCFCM2026-01-16
50192253068588DoverCardinal Health 200, LLCFCM2026-01-16
50192253068595DoverCardinal Health 200, LLCFCM2026-01-16
50192253068618DoverCardinal Health 200, LLCFCM2026-01-16
50192253068663DoverCardinal Health 200, LLCFCM2026-01-16
50192253068700DoverCardinal Health 200, LLCFCM2026-01-16
50192253067956DoverCardinal Health 200, LLCFCM2026-01-15
50192253067994DoverCardinal Health 200, LLCFCM2026-01-15
50192253068007DoverCardinal Health 200, LLCFCM2026-01-15
50192253070857DoverCardinal Health 200, LLCFCM2026-01-15
50192253027752DoverCardinal Health 200, LLCFCM2025-12-10
50192253028834DoverCardinal Health 200, LLCFCM2025-12-10
50192253030172DoverCardinal Health 200, LLCFCM2025-10-17
40704411019542AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019559AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019566AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019573AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019580AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019597AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019603AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019610AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019627AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019634AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019641AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01