FDA.reportPublic FDA data

BEDSIDE URINE COLLECTOR

Primary DI
04816415501270
Brand
BEDSIDE 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 to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. 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
04816415501270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04816415501270048164155012704816415501270

GMDN Terms#

Term, Definition table
TermDefinition
Non-wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. 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
04816415501379LARYNGEAL MASK Single Use Size 2N/A2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3N/A2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5N/A2026-05-27
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmN/A2026-05-27
04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmN/A2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmN/A2026-05-27
04816415501430BREATHING BAG single use 500N/A2026-05-27
04816415501447BREATHING BAG single use 1000N/A2026-05-27
04816415501454BREATHING BAG single use 2000N/A2026-05-27
04816415501461BREATHING BAG single use 3000N/A2026-05-27
04816415501478BREATHING BAG reusable 500N/A2026-05-27
04816415501485BREATHING BAG reusable 1000N/A2026-05-27
04816415501492BREATHING BAG reusable 2000N/A2026-05-27
04816415501508BREATHING BAG reusable 3000N/A2026-05-27
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEN/A2026-05-26
04816415501263FOOT 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253068603DoverCardinal Health 200, LLCKNX2026-01-16
10192253068719DoverCardinal Health 200, LLCKNX2026-01-16
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10192253068733DoverCardinal Health 200, LLCKNX2026-01-16
10192253067989DoverCardinal Health 200, LLCKNX2026-01-15
10192253068016DoverCardinal Health 200, LLCKNX2026-01-15
10192253068214DoverCardinal 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
10192253031379DoverCardinal Health 200, LLCKNX2024-10-14
10195327301927Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KNX2023-02-05