FDA.reportPublic FDA data

Dover

Primary DI
10884521157026
Brand
Dover
Company
Cardinal Health, Inc.
Model
8884730200
Catalog number
8884730200
Device description
Male External Catheter,Texas Style, Standard
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
10884521157026PackageGS1144In Commercial Distribution
20884521157023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452115702610884521157026
2088452115702320884521157023

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kitA collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not 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
Outer Diameter1.375Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521012301Monoject118030077711803007772016-09-24
10884521018266Monoject897089702016-09-24
10884521022782SharpSafety8512018512012016-09-24
10884521023253Monoject8506SA8506SA2016-09-24
10884521023369Monoject85221R85221R2016-09-24
10884521023482SharpSafety8534SA8534SA2016-09-24
10884521050310Argyle888856080588885608052016-10-06
10884521050747Argyle888856101988885610192016-09-24
10884521050754Argyle888856102788885610272016-09-24
10884521050761Argyle888856103588885610352016-09-24
10884521050778Argyle888856104388885610432016-09-24
10884521050785Argyle888856105088885610502016-09-24
10884521050792Argyle888856106888885610682016-09-24
10884521050808Argyle888856107688885610762016-10-06
10884521050815Argyle888857050788885705072016-09-24
10884521050822Argyle888857051588885705152016-09-24
10884521050839Argyle888857052388885705232016-09-24
10884521050846Argyle888857054988885705492016-09-24
10884521050853Argyle888857055688885705562016-09-24
10884521050877Argyle888857057288885705722016-09-24

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
10192253030037DoverCardinal Health 200, LLCEXJ2024-10-15
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