FDA.reportPublic FDA data

Dover

Primary DI
50192253028988
Brand
Dover
Company
Cardinal Health 200, LLC
Model
145501
Catalog number
145501
Device description
PEDIATRIC URINE SPECIMEN COLLECTOR, 100 ML
Published
2025-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
20192253028987PackageGS130In Commercial Distribution
50192253028988PackageGS110In Commercial Distribution
10192253028980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225302898720192253028987
5019225302898850192253028988
1019225302898010192253028980

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

Sterilization Methods#

Method table
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
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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344216956MEDLINEMEDLINE INDUSTRIES, INC.FFG2026-07-06
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
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
10884521004511DoverCardinal Health, Inc.FFG2016-09-24
10884521029620DoverCardinal Health 200, LLCFFG2016-09-24