FDA.reportPublic FDA data

Dover

Primary DI
10192253068214
Brand
Dover
Company
Cardinal Health 200, LLC
Model
6144ICLL
Catalog number
6144ICLL-
Device description
100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 14 FR (4.7 MM), 5CC, 2-WAY, 2000ML DRAIN BAG
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
KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253068212PackageGS110In Commercial Distribution
10192253068214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306821250192253068212
1019225306821410192253068214

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 Gauge14French
Total Volume2000Milliliter

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
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
10192253071108DoverCardinal Health 200, LLCKNX2026-06-24
10192253071139DoverCardinal Health 200, LLCKNX2026-06-24
10192253071146DoverCardinal Health 200, LLCKNX2026-06-24
10192253068603DoverCardinal Health 200, LLCKNX2026-01-16
10192253068719DoverCardinal Health 200, LLCKNX2026-01-16
10192253068726DoverCardinal Health 200, LLCKNX2026-01-16
10192253068733DoverCardinal Health 200, LLCKNX2026-01-16
10192253067989DoverCardinal Health 200, LLCKNX2026-01-15
10192253068016DoverCardinal Health 200, LLCKNX2026-01-15
10840330701799ProCureTwin Med, LLCKNX2025-05-31
10840330701805ProCureTwin Med, LLCKNX2025-05-31
10192253027792DoverCardinal Health 200, LLCKNX2025-04-01
10192253028232DoverCardinal Health 200, LLCKNX2025-04-01
10192253032161DoverCardinal Health 200, LLCKNX2025-04-01
20192253030058DoverCardinal Health 200, LLCKNX2025-04-01
10192253027945DoverCardinal Health 200, LLCKNX2025-03-20
10192253028461DoverCardinal Health 200, LLCKNX2024-12-20
10192253028522DoverCardinal Health 200, LLCKNX2024-12-20
10192253028539DoverCardinal Health 200, LLCKNX2024-12-20
10192253028546DoverCardinal Health 200, LLCKNX2024-12-20
10192253028560DoverCardinal Health 200, LLCKNX2024-12-20
10192253031126DoverCardinal Health 200, LLCKNX2024-12-20
10192253027938DoverCardinal Health 200, LLCKNX2024-11-04
10192253028287DoverCardinal Health 200, LLCKNX2024-11-04
10192253028492DoverCardinal Health 200, LLCKNX2024-11-04
10192253031447DoverCardinal Health 200, LLCKNX2024-11-04
10192253028195DoverCardinal Health 200, LLCKNX2024-10-14
10192253028201DoverCardinal Health 200, LLCKNX2024-10-14
10192253028263DoverCardinal Health 200, LLCKNX2024-10-14
10192253028386DoverCardinal Health 200, LLCKNX2024-10-14