FDA.reportPublic FDA data

Dover

Primary DI
10884521008427
Brand
Dover
Company
Cardinal Health, Inc.
Model
5027
Catalog number
5027
Device description
Universal Tray,Prepping Componets with 30 mL Pre-filled Syringe
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
PPCMale External Catheterization Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPCMale External Catheterization Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521008424PackageGS120Not in Commercial Distribution
10884521008427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100842420884521008424
1088452100842710884521008427

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
Total Volume30Milliliter

Storage And Handling#

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

Regulatory Flags#

DUNS number
080935429
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
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24
10884521154100Devon31146895311468952016-09-24
10192253059984Dover7014MF7014MF2022-06-07
10884521013230Monoject888122524188812252412016-09-24
10884521013254Monoject888122524588812252452016-09-24
10884521024854Kendall923892382018-06-27
10884521004498Dover1455001455002016-09-24
10884521014091Monoject888150164088815016402016-09-24
10884521163041Magellan888185005888818500582016-09-24
10884527021932Uni-PatchEP84580EP845802016-09-24
20884521012216Monoject888153578888815357882016-09-24
20884521012254Monoject888156018288815601822016-09-24
20884521014159Monoject888151613588815161352016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801741183628SureStep Male External Catheter SystemC. R. Bard, Inc.PPC2020-09-22
10801741183635SureStep Male External Catheter SystemC. R. Bard, Inc.PPC2020-09-22
10801741183642SureStep Male External Catheter System Orange Replacement KitC. R. Bard, Inc.PPC2020-09-22
10801741183659SureStep Male External Catheter System Green Replacement KitC. R. Bard, Inc.PPC2020-09-22
10801741183666SureStep Male External Catheter System Blue Replacement KitC. R. Bard, Inc.PPC2020-09-22
10801741183673SureStep Male External Catheter System Violet Replacement KitC. R. Bard, Inc.PPC2020-09-22
10888439561937CARDINAL HEALTHCardinal Health 200, LLCPPC2019-08-27
50888439561935CARDINAL HEALTHCardinal Health 200, LLCPPC2019-08-27
10888439548457CARDINAL HEALTHCardinal Health 200, LLCPPC2019-08-06
50888439548455CARDINAL HEALTHCardinal Health 200, LLCPPC2019-08-06
20884521001005DoverCardinal Health, Inc.PPC2016-09-24
20884521004433DoverCardinal Health, Inc.PPC2016-09-24
20884521005324DoverCardinal Health, Inc.PPC2016-09-24
20884521008424DoverCardinal Health, Inc.PPC2016-09-24
20884521008479DoverCardinal Health, Inc.PPC2016-09-24
20884521008486DoverCardinal Health, Inc.PPC2016-09-24
20884521008493DoverCardinal Health, Inc.PPC2016-09-24
20884521008516DoverCardinal Health, Inc.PPC2016-09-24
20884521008561DoverCardinal Health, Inc.PPC2016-09-24
20884521008592DoverCardinal Health, Inc.PPC2016-09-24
20884521008615DoverCardinal Health, Inc.PPC2016-09-24
20884521009377DoverCardinal Health, Inc.PPC2016-09-24
20884521009384DoverCardinal Health, Inc.PPC2016-09-24
20884521009421DoverCardinal Health, Inc.PPC2016-09-24
20884521009445DoverCardinal Health, Inc.PPC2016-09-24
20884521009476DoverCardinal Health, Inc.PPC2016-09-24
30884521009480DoverCardinal Health, Inc.PPC2016-09-24
20884521009490DoverCardinal Health, Inc.PPC2016-09-24
20884521009513DoverCardinal Health, Inc.PPC2016-09-24
20884521009575DoverCardinal Health, Inc.PPC2016-09-24