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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 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 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
Wireless Blood Glucose Monitoring System. 1 Kit.
For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
6262
In Commercial Distribution
- 0193-6262-01 ()
- 00301936262013 ()
85092979
- Glucose monitoring system IVD, home-use
Wireless Blood Glucose Monitoring System. 1 Kit.
For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
6260
In Commercial Distribution
- 00301936260019 ()
81914672
- Glucose monitoring system IVD, home-use
CELLUGEL 1.0ML 25G
CELLUGEL® Ophthalmic Viscosurgical Device (OVD) is a sterile, nonpyrogenic, noninflammatory viscoelastic solution of highly purified non-proteinaceous 2% Hydroxypropyl Methylcellulose (HPMC) with an average molecular weight of 300,000
daltons dissolved in an isotonic, physiological buffer.
Each mL of CELLUGEL® contains: 2% HPMC, 0.525% sodium chloride, 0.075% potassium chloride, 0.048% calcium chloride dihydrate, 0.03% magnesium chloride hexahydrate, 0.39% sodium acetate trihydrate, 0.17% sodium citrate dihydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid may be used as pH adjusters. The osmolarity of CELLUGEL® is 315 ± 35 mOsM/kg, the pH 7.2 ± 0.4, and the viscosity 30,000 ± 10,000 cps (at 0.2 sec-1, 25°C).
Alcon Laboratories, Inc.
8065183810
In Commercial Distribution
- 00380651838109 ()
- 20380651838103 ()
- Total Volume: 1 Milliliter
- Aqueous/vitreous humour replacement medium kit
Blood Glucose Test Strips - 25 Test Strips.
ASCENSIA DIABETES CARE US INC.
7310
In Commercial Distribution
- 40301939735253 ()
- 00301937310256 ()
- 10301937310253 ()
- 40301937310254 ()
- 0193-7310-25 ()
- 00301937310010 ()
83623099
- Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7309
In Commercial Distribution
- 40301937357501 ()
- 00301937309502 ()
- 10301937309509 ()
- 40301937309500 ()
- 0193-7309-50 ()
- 00301937309014 ()
83623080
- Glucose monitoring system IVD, home-use
Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses.
Baxter Healthcare Corporation
ADS201810
Not in Commercial Distribution
- 25413765583609 ()
- 05413765583605 ()
ADS201810
- Surgical internal adhesive/sealant, animal-derived