FDA.reportPublic FDA data

Dover

Primary DI
10192253030037
Brand
Dover
Company
Cardinal Health 200, LLC
Model
8884730600
Catalog number
8884730600
Device description
FOAM ADHESIVE STRAP 6X1 (15.9 CM X 2.5 CM)
Published
2024-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EXJDEVICE, INCONTINENCE, UROSHEATH TYPE, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXJDevice, Incontinence, Urosheath Type, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253030035PackageGS1500In Commercial Distribution
10192253030037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225303003550192253030035
1019225303003710192253030037

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
Length6Inch
Width1Inch

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
10192253030181DoverCardinal Health 200, LLCEXJ2025-04-01
20192253030188DoverCardinal Health 200, LLCEXJ2025-04-01
10192253030020DoverCardinal Health 200, LLCEXJ2024-12-17
10192253030099DoverCardinal Health 200, LLCEXJ2024-12-17
50192253030028DoverCardinal Health 200, LLCEXJ2024-12-17
50192253030097DoverCardinal Health 200, LLCEXJ2024-12-17
50192253030035DoverCardinal Health 200, LLCEXJ2024-10-15
06936881133381Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06936881133398Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06936881133435Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06936881133459Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725485Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725492Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725508Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725515Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725522Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725539Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725546Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725553Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725560Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16936881133388Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16936881133395Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16936881133432Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16936881133456Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725482Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725499Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725505Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725512Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725529Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725536Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11