FDA.report

Dover

Primary DI
20192253030188
Brand
Dover
Company
Cardinal Health 200, LLC
Model
8887600149
Catalog number
8887600149
Device description
Catheter Strap, Foam with Securing Adhesive, 30 in. (76.2 cm)
Published
2025-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EXJDEVICE, INCONTINENCE, UROSHEATH TYPE, STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
EXJDevice, Incontinence, Urosheath Type, SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253030188PackageGS110In Commercial Distribution
50192253030189PackageGS112In Commercial Distribution
10192253030181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225303018820192253030188
5019225303018950192253030189
1019225303018110192253030181

GMDN Terms

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

TypeValueUnit
Length30Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
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
false
No natural rubber latex
true
Sterilization required before use
false

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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 DIBrandCompanyProduct codePublished
50192253030028DoverCardinal Health 200, LLCEXJ2024-12-17
50192253030097DoverCardinal Health 200, LLCEXJ2024-12-17
50192253030035DoverCardinal Health 200, LLCEXJ2024-10-15
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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
16944932725543Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725550Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725567Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16936881133500Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16936881133524Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932725574Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730714Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730721Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730738Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730745Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730752Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
20884521050430DoverCardinal Health, Inc.EXJ2018-06-30
20884521003627DoverCardinal Health, Inc.EXJ2018-06-30
20884521007861DoverCardinal Health, Inc.EXJ2018-06-30
10884521003989DoverCardinal Health, Inc.EXJ2018-06-30
20884521003870DoverCardinal Health, Inc.EXJ2018-06-27
10884521157026DoverCardinal Health, Inc.EXJ2018-06-27