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The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1113
In Commercial Distribution
- 00853095008532 ()
- Balloon Diameter: 30 Millimeter
- Balloon Length: 45 Millimeter
- Balloon Rated Burst Pressure: 4 Atmosphere
1113-30045
- Urethral dilatation catheter, drug-eluting
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1137
In Commercial Distribution
- 00853095008426 ()
- Balloon Diameter: 30 Millimeter
- Catheter Length: 30 Millimeter
- Balloon Rated Burst Pressure: 4 Atmosphere
1137-30030
- Urethral dilatation catheter, non-medicated
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1113
In Commercial Distribution
- 00853095008402 ()
- Balloon Diameter: 30 Millimeter
- Balloon Length: 30 Millimeter
- Balloon Rated Burst Pressure: 4 Atmosphere
1113-30030
- Urethral dilatation catheter, drug-eluting
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1189
In Commercial Distribution
- 00853095008235 ()
- Balloon Diameter: 30 Millimeter
- Balloon Length: 35 Millimeter
- Balloon Rated Burst Pressure: 4 Atmosphere
1189-30035
- Urethral dilatation catheter, drug-eluting
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1189
In Commercial Distribution
- 00853095008181 ()
- Balloon Diameter: 30 Millimeter
- Balloon Length: 30 Millimeter
- Balloon Rated Burst Pressure: 4 Atmosphere
1189-30030
- Urethral dilatation catheter, drug-eluting
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1113
In Commercial Distribution
- 00853095008174 ()
- Balloon Diameter: 30 Millimeter
- Balloon Length: 40 Millimeter
- Balloon Rated Burst Pressure: 4 Atmosphere
1113-30040
- Urethral dilatation catheter, drug-eluting
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1113
In Commercial Distribution
- 00853095008129 ()
- Balloon Diameter: 30 Millimeter
- Balloon Length: 35 Millimeter
- Balloon Rated Burst Pressure: 4 Atmosphere
1113-30035
- Urethral dilatation catheter, drug-eluting
The LungFit PH Verification Kit (p/n 90015) is used during the Verification Check procedure to check the performance of the system before the system is attached to the patient circuit. The NDM is attached between the two open lengths of 22mm tubing and the gas sample line is attached to the sample T adaptor. A full description of how it is used is included in the LungFit PH Operators Manual section 9.3 (Beyond Air p/n 20038).
Beyond Air, Inc.
90015
In Commercial Distribution
- B882900151 ()
- B882900150 ()
- B882900152 ()
- Nitric oxide delivery unit, system-based
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1137
In Commercial Distribution
- 00853095008150 ()
- Balloon Diameter: 30 Millimeter
- Balloon Length: 35 Millimeter
- Balloon Rated Burst Pressure: 4 Atmosphere
1137-30035
- Urethral dilatation catheter, non-medicated
The Catheter Access Kit is sterile and provides the components and instructions necessary to access the catheter access port of the Prometra Programmable Pump. The catheter access port is located on the periphery of the pump to allow for direct access to the catheter without interfering with the drug reservoir.
Flowonix Medical, Inc.
11824
In Commercial Distribution
- 00810335020136 ()
- General surgical procedure kit, non-medicated, single-use