FDA.reportPublic FDA data

Dover

Primary DI
10884521004511
Brand
Dover
Company
Cardinal Health, Inc.
Model
145501
Catalog number
145501
Device description
Pediatric Urine Specimen Collector
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FFGDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFGDevice, Urine Flow Rate Measuring, Non-Electrical, DisposableGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521004518PackageGS130Not in Commercial Distribution
30884521004515PackageGS1300Not in Commercial Distribution
10884521004511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100451820884521004518
3088452100451530884521004515
1088452100451110884521004511

GMDN Terms#

Term, Definition table
TermDefinition
Midstream urine specimen container IVDA covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Milliliter

Storage And Handling#

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

Regulatory Flags#

DUNS number
080935429
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344156269MEDLINEMEDLINE INDUSTRIES, INC.FFG2025-08-05
10197344157884MEDLINEMEDLINE INDUSTRIES, INC.FFG2025-08-05
20197344156266MEDLINEMEDLINE INDUSTRIES, INC.FFG2025-08-05
20197344157881MEDLINEMEDLINE INDUSTRIES, INC.FFG2025-08-05
10192253028423DoverCardinal Health 200, LLCFFG2025-04-01
50192253028421DoverCardinal Health 200, LLCFFG2025-04-01
10192253028980DoverCardinal Health 200, LLCFFG2025-01-15
50192253028988DoverCardinal Health 200, LLCFFG2025-01-15
10888277678415MedlineMEDLINE INDUSTRIES, INC.FFG2021-09-16
20888277678412MedlineMEDLINE INDUSTRIES, INC.FFG2021-09-16
10888277678392MedlineMEDLINE INDUSTRIES, INC.FFG2021-01-05
20888277678399MedlineMEDLINE INDUSTRIES, INC.FFG2021-01-05
10080196998401MedlineMEDLINE INDUSTRIES, INC.FFG2020-12-23
10884389121191MedlineMEDLINE INDUSTRIES, INC.FFG2020-12-23
40080196998402MedlineMEDLINE INDUSTRIES, INC.FFG2020-12-23
40884389121192MedlineMEDLINE INDUSTRIES, INC.FFG2020-12-23
10704411013075AMSure® Urine Meter Drainage BagAMSINO INTERNATIONAL, INC.FFG2020-10-16
40704411013076AMSure® Urine Meter Drainage BagAMSINO INTERNATIONAL, INC.FFG2020-10-16
00801741019357Bard® CritiCore® Collection ContainerC. R. Bard, Inc.FFG2017-03-22
10801741019354Bard® CritiCore® Collection ContainerC. R. Bard, Inc.FFG2017-03-22
10080196749577MedlineMEDLINE INDUSTRIES, INC.FFG2016-10-14
10884389119495MedlineMEDLINE INDUSTRIES, INC.FFG2016-10-14
10888277136946MedlineMEDLINE INDUSTRIES, INC.FFG2016-10-14
40888277136947MedlineMEDLINE INDUSTRIES, INC.FFG2016-10-14
10884521029583DoverCardinal Health 200, LLCFFG2016-09-28
20884521029580DoverCardinal Health, Inc.FFG2016-09-28
10884521002180DoverCardinal Health 200, LLCFFG2016-09-24
10884521004498DoverCardinal Health, Inc.FFG2016-09-24
10884521029620DoverCardinal Health 200, LLCFFG2016-09-24
10884521029644DoverCardinal Health 200, LLCFFG2016-09-24