FDA.reportPublic FDA data

Dover

Primary DI
10192253068207
Brand
Dover
Company
Cardinal Health 200, LLC
Model
2118IC
Catalog number
2118IC
Device description
100% SILICONE SILVER-HYDROGEL COATED FOLEY INSERTION TRAY, 5 CC, PREP TRAY, 18 FR (6.0 MM)
Published
2026-01-15
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
PPBFoley catheter kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPBFoley Catheter Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253068205PackageGS120In Commercial Distribution
10192253068207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306820550192253068205
1019225306820710192253068207

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 Volume5Milliliter

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
Combination product
true
Lot or batch
true
Expiration date on label
true

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
10192253068191DoverCardinal Health 200, LLCPPB2026-01-15
10192253030525DoverCardinal Health 200, LLCPPB2024-12-20
10192253030532DoverCardinal Health 200, LLCPPB2024-12-20
10193489987126Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489987133Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988369Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988529Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988611Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988628Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489987119Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987294Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987300Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987386Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987393Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987409Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987416Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987423Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987430Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987447Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987454Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987461Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987577Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987676Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987683Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987690Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987706Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987942Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30