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The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System.
The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.
Endotronix, Inc.
100102-01
In Commercial Distribution
- 00850008997013 ()
- Implantable pulmonary artery pressure monitoring system
The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative detection of the BRAF V600E and V600K mutations in human melanoma tissue
BIOMERIEUX SA
410697
In Commercial Distribution
- 03573026354909 ()
410697
- BRAF gene mutation IVD, kit, nucleic acid technique (NAT)
Zeller Power's Cardiac Science 9146-102/202/302 medical replacement battery is rated at 12V, 7.5Ah, 90 Wh. This replacement battery for Cardiac Science 9146-102/202/302 is 100% compatible.
RECHARGEABLE POWER ENERGY NORTH AMERICA LLC
ZP9146Y
In Commercial Distribution
- 00860002738017 ()
- 00860002738000 ()
- Disposable battery pack
OPTIMIZER Lite Implantable Pulse Generator for the Treatment of Heart Failure
System consists of:
(1) OPTIMIZER Lite Implantable Pulse Generator (IPG)
(1) Allen #2 torque wrench
(1) Port Plug
Impulse Dynamics (usa) Inc.
Lite
In Commercial Distribution
- 00810003380142 ()
10-B502-3-XX
- Cardiac contractility modulation system pulse generator
OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure
System consists of:
(1) OPTIMIZER Smart Implantable Pulse Generator (IPG)
(1) Allen #2 torque wrench
(1) Port Plug
Impulse Dynamics (usa) Inc.
CCM X10
In Commercial Distribution
- 00810003380050 ()
10-B411-3-XX
- Cardiac contractility modulation system pulse generator
OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure
System consists of:
(1) OPTIMIZER Smart Implantable Pulse Generator (IPG)
(1) Allen #2 torque wrench
(1) Port Plug
Impulse Dynamics (usa) Inc.
CCM X10
In Commercial Distribution
- 00810003380005 ()
10-B411-3-US
- Cardiac contractility modulation system pulse generator
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 Eversense Insertion Tools Tray includes the Insertion Tool and the Blunt Dissector. The tray is a component of the Insertion Tools Kit that is used for Sensor insertion and removal.
SENSEONICS, INCORPORATED
101973-010
In Commercial Distribution
- 00817491022493 ()
N/A
- Subcutaneous implantation kit, non-medicated
Examination electrodes, used when performing measurements with the Nevisense on patients. Each electrode can be used up to 20 times for a single patient on several lesions in a single procedure.
Scibase AB
131-0007
In Commercial Distribution
- 07350094440200 ()
131-0007
- Neoplasm electrical impedance spectrometer electrode array
OPTIMIZER Smart Mini Implantable Pulse Generator for the Treatment of Heart Failure
System consists of:
(1) OPTIMIZER Smart Mini Implantable Pulse Generator (IPG)
(1) Allen #2 torque wrench
(1) Port Plug
Impulse Dynamics (usa) Inc.
Smart Mini
In Commercial Distribution
- 00810003380098 ()
10-B501-3-XX
- Cardiac contractility modulation system pulse generator