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Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying.

Hydrophilic intermittent catheter is a sterile, single use hollow tube inserted into the bladder to drain the urine at regular intervals. The catheter also contains a Polyvinyl Pyrrolidone hydrophilic-coating and is sterilized by irradiation. The product can be used on patients who need intermittent urine drainage. The Hydrophilic intermittent catheter is available for use in professional medical facilities and home environments. The Hydrophilic Intermittent Catheter Ready to Use is placed in a wetting liquid, packed and sealed in a foil pouch and sterilized. The Hydrophilic Intermittent Catheter Compact is placed in a wetting liquid inside the container, which together with screw cap, connector and plug make up the primary packaging and the sterile barrier. The Hydrophilic Intermittent Catheter Ready to Use is available in three configurations: - Ready to use Female (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr) - Ready to use Standard (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr) - Ready to use Tiemann (10Fr, 12Fr, 14Fr, 16Fr, 18Fr) . The Hydrophilic Intermittent Catheter Compact is available in one configuration (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 16Fr).

Intermittent drainage of the urinary bladder of Adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. The target population for GC Air for Men is male adults and includes Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).

GC Air for Men is a sterile, single use, disposable, hydrophilic, intermittent, urethral catheter. It is designed for portability, ease of use and discreet disposal, with FeelClean™ technology for superior comfort and less sticky residue. The catheter comprises of a flexible tube and color-coded funnel, both made from plastic materials (Polyvinyl Chloride; PVC). The catheter tube is made using thermoplastic elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. Catheters are individually packed into a sealed foil primary pouch along with a sterile (E-Beam) water sachet and handling sleeve, prior to secondary and tertiary packing and sterilization by X-Ray irradiation. The water sachet is provided for wetting of the hydrophilic surface and is burst at the point of use. The handling sleeve is provided to minimize touching the catheter shaft directly during insertion and retraction.

The intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

The Intermittent Catheter (final name to be determined) is a hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinent Catheter is inserted into the urethra to drain urine from the bladder. The Intermittent Catheter is available in 7 in. and 16 in. lengths. The 7 in. catheter is available in sizes 8, 10, 12, 14 Fr and the 16 in. catheter is available in sizes 8, 10, 12, 14, 16 Fr. The Intermittent Catheter is provided sterile, using e-beam Irradiation sterilization. The device is made from Thermo-plastic Elastomer (TPE), and is phthalate free, PVC free. This directly hydrated catheter is packaged in a peel-able 4 sided pouch which was designed to be easy to open and to facilitate access to the catheter. The primary pack contains both the catheter assembly and the hydration fluid in one compartment. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid There is a gripper on the 16 inch catheter to aid with the insertion process, if desired.

SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for males only.

The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for males. It is a single use catheter with an integrated urine bag. The catheter is a hollow tube consisting of polyurethane and methylmethacrylate-acrylonitrilebutadiene-styrene polymer [MABS]. It facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in one size FR/CH 12/18. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) containing polyethylene glycol (PEG) inside a tube. The swelling medium resides between the catheter and the tube and lubricates the catheter.

SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for females only.

The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for females. It is a single use catheter with an integrated urine bag. The catheter is a hollow polyurethane tube that facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in three sizes FR/CH 10, FR/CH 12 and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside a tube, which together with a cover and plug make up the primary packaging and the sterile barrier. The subject device is the same as the predicate device, apart from the swelling medium. The swelling medium resides between the catheter and the tube and lubricates the catheter. The swelling medium in the subject device contains polyethylene glycol (PEG), and the predicate contains polyvinylpyrrolidone (PVP).

SpeediCath Soft is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The cather is inserted into the bladder allowing urine to drain. The product is for adult male patients only.

The SpeediCath Soft is a sterile, single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by adult males with missing or reduced bladder control. The catheter has a grip which serves as protection from the user's touch and aids the user during insertion.

Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.

Jimushi Sterile Urethral Catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men. This product is supplied in three slightly different forms: 1) Common model (conventional uncoated type), 2) Hydrophilic coated model, 3) Hydrophilic coated with water pocket model. The catheter body is made of polyvinyl chloride (PVC) with or without hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel shaped connector at the proximal end can be connected to a urine collection container. The catheter body is sterilized by EO, where the water pocket in some models is pre-sterilized by radiation.

The LotusCatheter (Lotus No Balloon Catheter) is used for continuous drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The LotusCatheter (Lotus No Balloon Catheter) is to be used in patients 5 years of age or older.

The Lotus No Balloon Catheter is a sterile, single patient use drainage catheter made of silicone elastomer. The catheter is used to pass fluids to and from the urinary tract, suprapubically or through the nephrostomy tract. The catheter is supplied in French sizes ranging from 8Fr to 26Fr.

Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.

The proposed B. Braun Actreen® Hi-Lite Intermittent Urinary Catheter devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. These Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 7.5 inch length with a variety of French gauge sizes ranging from 6-16 with a straight tip. The outer packaging was designed to facilitate easier, no touch access for those with limited dexterity, while the hydrophilic lubrication makes this single use catheter ready to use.

This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

This submission is to add an additional size (Fr 08) to the currently cleared 16-inch Pocket and Plus Pocket configurations of VaPro 2. The VaPro 2 Pocket Line Extension is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. VaPro 2 Pocket Line Extension has the following features: - Hydrophilic-coated PVC catheter (phthalate free) - Two smooth catheter eyelets - Protective sleeve - Protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion - Color-coded funnel. - Urine Collection bag (for the Plus Pocket version) The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The outer packaging is designed to facilitate access for those with limited dexterity. The Pocket version is designed to be discreet and easy to store. In the Plus Pocket configuration, the urinary catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.