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510(k) Data Aggregation
K Number
K160795Device Name
United Urologics Intermittent Catheter
Manufacturer
Date Cleared
2016-06-16
(85 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
ROBLING MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
United Urologics Intermittent Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
Device Description
The United Urologics Intermittent Catheter is a sterile, single use, disposable, urinary incontinence device designed to drain urine from the bladder. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter may be provided with a funnel bonded to the end of the catheter tube opposite the tipped end. During use, the funnel or flared end of the catheter may be attached to a universal adapter to facilitate drainage of the urine into a standard urinary collection bag (the collection bag and universal adapter are not part of this device).
The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facilitate drainage of urine from the bladder.
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K Number
K160877Device Name
United Urologics Closed System Catheter
Manufacturer
Date Cleared
2016-05-20
(51 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
ROBLING MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
United Urologics Closed System Intermittent Catheterization kit is intended to be used to drain urine from the patient's bladder into a collection bag.
Device Description
The United Urologics Closed System Catheter is a pre-lubricated sterile, single use, disposable, urinary incontinence device designed to drain urine from the patient's bladder into a urine collection bag. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter is provided with a funnel bonded to the end of the catheter tube opposite the tipped end. The catheter is prelubricated with a water soluble lubricant and sealed in a urine collection bag. It is designed with a molded silicone tip at the top of the bag which acts as an introducer sheath for the tip of the catheter. This introducer and holding mechanism on the inside of the bag, provide a mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter.
The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facility to facilitate drainage of urine from the bladder.
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