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The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-002-007
In Commercial Distribution
- 10855728005199 ()
4323
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached
breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide,
nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80013
In Commercial Distribution
- B882800130 ()
- Nitric oxide delivery unit, system-based
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached
breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide,
nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80012
In Commercial Distribution
- B882800120 ()
- Nitric oxide delivery unit, system-based
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
ACCY 3550-03 TWISTLOCK SCREENCABLE
MEDTRONIC, INC.
3550-03
Not in Commercial Distribution
- 00643169953567 ()
- Neurosurgical procedure kit, non-medicated, single-use
ACCY KIT 3550-03 DBS TWSTLCK SCRNCBL FWU
MEDTRONIC, INC.
3550-03
Not in Commercial Distribution
- 00643169887435 ()
- Neurosurgical procedure kit, non-medicated, single-use
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).
Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
2
In Commercial Distribution
- 04053228043560 ()
874721
- Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X200
In Commercial Distribution
- 00860008946478 ()
- 6.7mm Stent Graft Proximal Diameter
- 6.7mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 200mm Covered Stent Graft Length
TSG-6.7X200
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X150
In Commercial Distribution
- 00860008946461 ()
- 6.7mm Stent Graft Proximal Diameter
- 6.7mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 150mm Covered Stent Graft Length
TSG-6.7X150
- Central/peripheral venous endovascular stent-graft