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OCS Lung Solution
TRANSMEDICS, INC.
2300
In Commercial Distribution
- B00944671 ()
- B00944670 ()
- Height: 2.5 Inch
- Width: 5.5 Inch
- Length: 14 Inch
2300
- Donor-organ/tissue/cell preservation solution
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
V1
In Commercial Distribution
- 04053228034094 ()
874721
- Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution
- 00860001218275 ()
SFW-2012
- Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
The Access Hybritech free PSA Calibrators are intended to calibrate the Access Hybritech free PSA assay for the quantitative determination of free PSA levels in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
37215
In Commercial Distribution
- H628372151 ()
37215
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast. The Digital Breast Tomosynthesis imaging uses high-resolution Tomosynthesis, known as Clarity HD.
Hologic, Inc.
ASY-11748-CHD
In Commercial Distribution
- 15420045511897 ()
ASY-11748-CHD
- Stationary mammographic x-ray system, digital
The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained individuals. It provides simple and direct voice prompts and indications for a straightforward rescue operation. The i-PAD NF1200 needs the user to press its SHOCK button to deliver a defibrillating shock. During a rescue operation, it continuously acquires the electrocardiogram (ECG) of the patient. It also conducts arrhythmia detection continuously except during cardiopulmonary resuscitation (CPR). The timing and duration of the CPR are in accordance with the recommendations of the American Heart Association (AHA) 2005 Guidelines for CPR and Emergency Cardiovascular Care (ECC). The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.)
It delivers a 150-Joule biphasic truncated exponential shock waveform that it compensates for patient impedance by adjusting its timing parameter. If the user decides not to deliver a charge, the i-PAD NF1200 disarms itself by dumping the charge into an internal resistive load.
The i-PAD NFI200 is capable of saving data and transmitting them to an external device.
Indications for Use
The i-PAD NFI200 is used to treat a person suffering from sudden cardiac arrest
(SCA) and who exhibits symptoms of
· No movement and no response when shaken
· No normal breathing
Contraindication for Use
The device must not be used on a person who:
* Is moving or is responsive when shaken
* Is breathing normally
Target Patients
* Adults
* Children over 55 lbs or 8 years old
* The device is not to be used on children below 8 years old or under 55 lbs
Intended User
The device is intended for use by persons:
* who have been specifically trained in its operation
* who have training in cardiopulmonary resuscitation (CPR) or other physician-authorized emergency medical response program in accordance with local and state requirements
CU Medical Systems, Inc.
NF1200
In Commercial Distribution
- 08809435480003 ()
- Non-rechargeable public semi-automated external defibrillator
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered.
The Final Fit software has two major functions:
1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000
2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.12
In Commercial Distribution
- 04987669100042 ()
- Ophthalmic excimer laser system
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered.
The Final Fit software has two major functions:
1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000
2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.11US
In Commercial Distribution
- 04987669100035 ()
- Ophthalmic excimer laser system
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.13
In Commercial Distribution
- 04987669101346 ()
- Ophthalmic excimer laser system
FOR USE WITH: CODMAN 3000 Series Tapered Silicone Rubber Catheter (Radiopaque) with Connector Contents: (1) Catheter: O.D. 2.3mm tapered to O.D. 1.5mm x I.D. 0.6mm x 51.7cm long with (1) Universal Barbed Connector
Medos International Sàrl
IP-37957
In Commercial Distribution
- 10886704044086 ()
IP37957
- Spinal port/catheter