FDA.reportPublic FDA data

FOOT URINE COLLECTOR

Primary DI
04816415501263
Brand
FOOT URINE COLLECTOR
Company
ASSOMEDIKA, OOO
Model
N/A
Device description
A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.
Published
2026-05-26
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
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
04816415501263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04816415501263048164155012634816415501263

GMDN Terms#

Term, Definition table
TermDefinition
Wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.

Regulatory Flags#

DUNS number
683522555
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEN/A2026-05-26
04816415501270BEDSIDE URINE COLLECTORN/A2026-05-26
04816415501287BREATHING MASK Single Use Size 0N/A2026-05-26
04816415501294BREATHING MASK Single Use Size 3N/A2026-05-26
04816415501300BREATHING MASK Single Use Size 6N/A2026-05-26
04816415501317BREATHING MASK Reusable Size 0N/A2026-05-26
04816415501324BREATHING MASK Reusable Size 3N/A2026-05-26
04816415501331BREATHING MASK Reusable Size 5N/A2026-05-26
04816415501348OXYGEN MASK Single Use Size 4 with nebulizerN/A2026-05-26
04816415501355OXYGEN MASK Single Use Size 4 with bagN/A2026-05-26
04816415501362OXYGEN MASK Single Use Size 4N/A2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501270BEDSIDE URINE COLLECTORASSOMEDIKA, OOOKNX2026-05-26
50192253068601DoverCardinal Health 200, LLCKNX2026-01-16
50192253068717DoverCardinal Health 200, LLCKNX2026-01-16
50192253068724DoverCardinal Health 200, LLCKNX2026-01-16
50192253068731DoverCardinal Health 200, LLCKNX2026-01-16
50192253067987DoverCardinal Health 200, LLCKNX2026-01-15
50192253068014DoverCardinal Health 200, LLCKNX2026-01-15
50192253068212DoverCardinal Health 200, LLCKNX2026-01-15
16974500612586Disposable Urinary Drainage BagGCMEDICA ENTERPRISE LTD.(WUXI)KNX2025-08-07
30840330701793ProCureTwin Med, LLCKNX2025-05-31
30840330701809ProCureTwin Med, LLCKNX2025-05-31
50192253027790DoverCardinal Health 200, LLCKNX2025-04-01
50192253028230DoverCardinal Health 200, LLCKNX2025-04-01
50192253032169DoverCardinal Health 200, LLCKNX2025-04-01
50192253030059DoverCardinal Health 200, LLCKNX2025-04-01
50192253027943DoverCardinal Health 200, LLCKNX2025-03-20
50850045818390TruCathHR PHARMACEUTICALS INC.KNX2025-02-17
50850045818406TruCathHR PHARMACEUTICALS INC.KNX2025-02-17
50192253028568DoverCardinal Health 200, LLCKNX2024-12-20
50192253028520DoverCardinal Health 200, LLCKNX2024-12-20
50192253028537DoverCardinal Health 200, LLCKNX2024-12-20
50192253028544DoverCardinal Health 200, LLCKNX2024-12-20
50192253028469DoverCardinal Health 200, LLCKNX2024-12-20
50192253031124DoverCardinal Health 200, LLCKNX2024-12-20
50192253028551DoverCardinal Health 200, LLCKNX2024-12-20
50192253027936DoverCardinal Health 200, LLCKNX2024-11-04
50192253028285DoverCardinal Health 200, LLCKNX2024-11-04
50192253028490DoverCardinal Health 200, LLCKNX2024-11-04
50192253031445DoverCardinal Health 200, LLCKNX2024-11-04
50192253028193DoverCardinal Health 200, LLCKNX2024-10-14