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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Urolux® Urinary and Ostomy Appliance Cleanser & Deodorant, Trial 4 oz. (118 mL.) - 00792293702043

CLEANSER, APPLIANCE, URINARY, OSTOMY, DEODORANT, ACID BASED, CITRUS SCENTED, TRIAL BOTTLE 4 OZ. (188 ML.) Rinsing alone does not clean a urinary or ostomy appliance and the use of vinegar, bleaches or toilet bowl cleaners only hardens, distorts and damages rubber, latex and plastic parts—not to mention the unpleasant and embarrassing odors often created by the use of these chemicals. Urocare® recommends the use of Urolux® urinary and ostomy appliance cleanser and deodorant for cleaning latex or rubber urinary leg bags, male urinal sheaths, urinary drainage bottles, urinary drainage and extension tubing or any other reusable urinary or ostomy appliance. Urolux® is a concentrated solution specifically formulated to clean and deodorize rubber, latex or plastic urinary and ostomy appliances. Crystal build-ups are dissolved and unpleasant odors are eliminated. Don't let corrosion happen to your urinary or ostomy appliance... Use Urolux! Features: • Effectively Cleans the Entire Fluid Pathway • Fresh Citrus Scent • Concentrated Formula Goes A Long Way • Dissolves Calcium and Urine Crystal Build-Ups • For use with Urinary & Ostomy Appliances PRECAUTIONS: Urolux contains phosphoric acid which may cause burns to skin and eyes. Avoid contact with all materials other than glass, plastics, rubber and latex. Avoid contamination of food and contact with skin and eyes. Use only as directed. Keep out of reach of children.
UROCARE PRODUCTS, INC.
700204
In Commercial Distribution

  • 10792293702040 ()
  • 00792293702043 ()

  • Total Volume: 118 Milliliter
  • Total Volume: 4 Fluid Ounce
  • Trial Bottle
  • Outer Diameter: 1.75 Inch
  • Height: 5.25 Inch
  • Weight: 0.34 Pound
700204

  • Penis/scrotum wearable urinal
  • Non-wearable adult urine collection bag, open-ended
  • Open-ended wearable urine collection bag, non-sterile
  • Hand-held urinal, reusable
  • Urinary incontinence penis sheath/port, single-use

Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.) - 00792293702166

CLEANSER, APPLIANCE, URINARY, OSTOMY, DEODORANT, ACID BASED, CITRUS SCENTED, STANDARD BOTTLE 16 OZ. (473 ML.) Rinsing alone does not clean a urinary or ostomy appliance and the use of vinegar, bleaches or toilet bowl cleaners only hardens, distorts and damages rubber, latex and plastic parts—not to mention the unpleasant and embarrassing odors often created by the use of these chemicals. Urocare® recommends the use of Urolux® urinary and ostomy appliance cleanser and deodorant for cleaning latex or rubber urinary leg bags, male urinal sheaths, urinary drainage bottles, urinary drainage and extension tubing or any other reusable urinary or ostomy appliance. Urolux® is a concentrated solution specifically formulated to clean and deodorize rubber, latex or plastic urinary and ostomy appliances. Crystal build-ups are dissolved and unpleasant odors are eliminated. Don't let corrosion happen to your urinary or ostomy appliance... Use Urolux! Features: • Effectively Cleans the Entire Fluid Pathway • Fresh Citrus Scent • Concentrated Formula Goes A Long Way • Dissolves Calcium and Urine Crystal Build-Ups • For use with Urinary & Ostomy Appliances PRECAUTIONS: Urolux contains phosphoric acid which may cause burns to skin and eyes. Avoid contact with all materials other than glass, plastics, rubber and latex. Avoid contamination of food and contact with skin and eyes. Use only as directed. Keep out of reach of children.
UROCARE PRODUCTS, INC.
700216
In Commercial Distribution

  • 10792293702163 ()
  • 00792293702166 ()

  • Weight: 1.30 Pound
  • Height: 8.25 Inch
  • Outer Diameter: 2.50 Inch
  • Standard
  • Total Volume: 16 Fluid Ounce
  • Total Volume: 473 Milliliter
700216

  • Urinary incontinence penis sheath/port, single-use
  • Hand-held urinal, reusable
  • Open-ended wearable urine collection bag, non-sterile
  • Non-wearable adult urine collection bag, open-ended
  • Penis/scrotum wearable urinal

X SERIES MONITOR/DEFIBRILLATOR - 00847946045470

X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, TEMP, CPR EXPANSION PACK, ETCO2, DMST
Zoll Medical Corporation
610-0121411-01
In Commercial Distribution

  • 00847946045470 ()


  • Noninvasive device battery charger
  • Internal defibrillation electrode, paediatric
  • Multifunction cardiac electrode, paediatric
  • Blood pressure cuff, single-use
  • External defibrillation electrode, paediatric, reusable
  • Internal defibrillation electrode, adult, reusable
  • Nasal oxygen cannula, carbon-dioxide-sampling
  • External defibrillation electrode, adult, single-use
  • Electrocardiographic electrode, single-use
  • Rechargeable professional automated external defibrillator

ZENSOR - 05060484630082

The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body. The device is to be used in the patient’s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The physiological parameters monitored include ECG and Respiration waveforms, Heart Rate and Respiration Rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation). The zensor monitoring device has the option to store full disclosure ECG & Respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician.
INTELESENS LIMITED
PN1287
In Commercial Distribution

  • 15060484630089 ()
  • 05060484630082 ()


  • Electrocardiography telemetric monitoring system

ZENSOR - 05060484630006

The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body. The device is to be used in the patient’s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The physiological parameters monitored include ECG and Respiration waveforms, Heart Rate and Respiration Rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation). The zensor monitoring device has the option to store full disclosure ECG & Respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician.
INTELESENS LIMITED
PN0620
In Commercial Distribution

  • 15060484630003 ()
  • 05060484630006 ()


  • Electrocardiography telemetric monitoring system
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