FDA.reportPublic FDA data

Dover

Primary DI
10192253031935
Brand
Dover
Company
Cardinal Health 200, LLC
Model
P4P18XCSDK
Catalog number
P4P18XCSDK
Device description
100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUDE TIP, 18FR (6.0 MM), 5CC, CSD
Published
2026-02-24
Public version status
New
Distribution status
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
PPGUrinary drainage collection kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPGUrinary Drainage Collection KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253031933PackageGS110In Commercial Distribution
10192253031935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225303193350192253031933
1019225303193510192253031935

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071085DoverCardinal Health 200, LLCPPG2026-06-24
10192253071092DoverCardinal Health 200, LLCPPG2026-06-24
10192253068023DoverCardinal Health 200, LLCPPG2026-06-23
10192253068030DoverCardinal Health 200, LLCPPG2026-06-23
10192253068047DoverCardinal Health 200, LLCPPG2026-06-23
10192253068054DoverCardinal Health 200, LLCPPG2026-06-23
10192253031843DoverCardinal Health 200, LLCPPG2026-03-20
50192253031841DoverCardinal Health 200, LLCPPG2026-03-20
10192253031799DoverCardinal Health 200, LLCPPG2026-02-24
10192253031881DoverCardinal Health 200, LLCPPG2026-02-24
10192253032048DoverCardinal Health 200, LLCPPG2026-02-24
10192253032093DoverCardinal Health 200, LLCPPG2026-02-24
10192253068627DoverCardinal Health 200, LLCPPG2026-01-16
10192253068634DoverCardinal Health 200, LLCPPG2026-01-16
10192253068641DoverCardinal Health 200, LLCPPG2026-01-16
10192253068658DoverCardinal Health 200, LLCPPG2026-01-16
10192253068672DoverCardinal Health 200, LLCPPG2026-01-16
10192253068689DoverCardinal Health 200, LLCPPG2026-01-16
10192253068696DoverCardinal Health 200, LLCPPG2026-01-16
50192253068625DoverCardinal Health 200, LLCPPG2026-01-16
50192253068632DoverCardinal Health 200, LLCPPG2026-01-16
50192253068649DoverCardinal Health 200, LLCPPG2026-01-16
50192253068656DoverCardinal Health 200, LLCPPG2026-01-16
50192253068670DoverCardinal Health 200, LLCPPG2026-01-16
50192253068687DoverCardinal Health 200, LLCPPG2026-01-16
50192253068694DoverCardinal Health 200, LLCPPG2026-01-16
10192253067965DoverCardinal Health 200, LLCPPG2026-01-15
10192253067972DoverCardinal Health 200, LLCPPG2026-01-15
50192253067963DoverCardinal Health 200, LLCPPG2026-01-15
50192253067970DoverCardinal Health 200, LLCPPG2026-01-15