FDA.reportPublic FDA data

Dover

Primary DI
10884521029644
Brand
Dover
Company
Cardinal Health 200, LLC
Model
P4P18XSD
Catalog number
P4P18XSD
Device description
100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 18 FR (6.0 MM), 5 CC, CATH SECURE
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
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
20884521029641PackageGS110Not in Commercial Distribution
10884521029644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102964120884521029641
1088452102964410884521029644

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
Catheter Gauge18French
Total Volume400Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

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
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
10884521004511DoverCardinal Health, Inc.FFG2016-09-24