FDA.reportPublic FDA data

Dover

Primary DI
10884521004498
Brand
Dover
Company
Cardinal Health, Inc.
Model
145500
Catalog number
145500
Device description
True content to be populated as part of rebranding
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
20884521004495PackageGS110Not in Commercial Distribution
10884521004498PrimaryGS10
30884521004492Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100449520884521004495
1088452100449810884521004498
3088452100449230884521004492

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 Volume0

Regulatory Flags#

DUNS number
080935429
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10884521004511DoverCardinal Health, Inc.FFG2016-09-24
10884521029620DoverCardinal Health 200, LLCFFG2016-09-24
10884521029644DoverCardinal Health 200, LLCFFG2016-09-24