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The Pollogen Legend+ system is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3). Pollogen Legend+ system is composed of a console, VO hand held applicator and disposable tips, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins. It is also composed of 3 treatment applicators, foot switch and patient-controlled manual switch. User interface allows the selection of treatment parameters: applicator, power and time and displays the current settings. The RF module provides RF energy to applicators at 1 MHz frequency. The treatment applicators transmit Bi-Polar RF energy through multiple electrode configuration which produces homogenous heating of the treatment area.
POLLOGEN LTD
POLLOGEN LEGEND+
In Commercial Distribution
- 07290016586008 ()
30009000U
- Radio-frequency skin surface treatment system
The Defender Room Air Cleaner ("Defender") is a portable, mechanical air filtration system
designed for single use int he home environment. It is configured as a circular unit with a
protective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiency
and particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses and
odors. During operation, air is drawn into the lower assembly, passes through the upper
assembly providing a 360-degree flow of air. The unit is equipped with a scent generator
powered by a small heating element. Outlet filtered air passes through the scent generator
and out from the top of the unit.
The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron in
size. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, mold
and pet allergens. The Defender is also intended to remove Tobacco smoke and other
household odors.
Health Mor At Home Cbp
D11NA
In Commercial Distribution
- 00863342000318 ()
- High-efficiency filter air cleaner, mobile
The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wave (CW) mode or a pulsed wave (PW) mode at manufacture (not programmable by the user). The Reprieve by Regenesis SWD device includes a base control unit, one or two treatment applicators, and an external power supply. The base control unit and treatment applicator(s) are enclosed in an injection-molded case made of medical grade poly carbonate. The treatment applicator(s) and power supply are attached to the base control unit. When not in use, the control unit acts as its own carrying case with the treatment applicators stored a slot in the Control Unit, the power supply stored in an attached pouch behind the control unit, and the treatment applicator cables stored using an attached cable management loop. The Reprieve by Regenesis SWD device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Regenesis Biomedical, Inc.
A
In Commercial Distribution
- 00868924000038 ()
- Short-wave diathermy treatment system, home-use
The LifeWarmer Quantum Thermal Transfusion Set- Blood is the revolutionary IV tubing set that allows for safe, rapid warming of blood, blood products, or IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard blood infusion tubing, the familiar configuration allows for ease of use. The sophisticated intelligence and proprietary warming technology are integrated into the tubing system for simplicity and to reduce additional equipment and procedural steps. Roughly the same size and weight as standard blood tubing, there is almost no additional equipment burden.
The Quantum IV administration tubing is double-extruded to yield a configuration that has both an inner tubing layer and an outer tubing layer. A conductive heating element is between the two layers but does not come in contact with the fluid path or disrupt the laminar flow. The outer tubing layer acts as an insulator while the inner tubing layer transfers the heat from the heating element to the fluid path. Thermistors (thermal resistors) located in the tubing continually measure temperature and provide that input to the Quantum Controller. The monitoring and independent application of energy (heat) along the fluid path allows the Quantum to respond to varying temperature inputs from the fluid source to near the point of patient entry to ensure fluid temperature is the right temperature at delivery.
The Quantum Life Warmer, fully charged, is able to warm and maintain up to 2 units ( 900mL +/- 100mL) of cold (4C) blood products or IV solutions to a pre-set temperature of 100.4F (38+/- 2C) at a flow rate of 100 mL/min (depending on the ambient temperature). Or, approximately 1700 mL of 20C IV solution to a set point of 38C +/- 2C at a flow rate of 200 mL/min. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions.
NORTH AMERICAN RESCUE, LLC
63-5904
In Commercial Distribution
- 00868058000454 ()
- 00868058000416 ()
35-0005
- Conduction blood/fluid warmer set
The VIA procedure kit - custom includes chux pad, gauze pads, lubricating jelly, suction tubing, gowns, O2 CO2 tubing, and BioGuard 4-piece kit.
US Endoscopy
00717132
00717132
- Endoscopy preparation kit
The VIA procedure kit - custom includes transport pad, gauze pads, enzymatic sponge, basin, syringe, biohazard sticker, lubricating jelly, gown, and DuoSwift combination squeegee brush.
US Endoscopy
00717131
00717131
- Endoscopy preparation kit
The VIA procedure kit-custom includes transport pad, gauze pads, basin, enzymatic sponge, biohazard sticker, lubricating jelly, and gowns.
US Endoscopy
00717130
00717130
- Endoscopy preparation kit
The VIA procedure kit-custom includes transport pad, gauze pads, basin, enzymatic sponge, and lubricating jelly.
US Endoscopy
00717129
00717129
- Endoscopy preparation kit
The VIA procedure kit - custom includes transport pad, gauze pads, basin, enzymatic sponge, suction tubing, biohazard sticker, lubricating jelly, syringe, DuoSwift combination squeegee brush and BioShield biopsy valve.
US Endoscopy
00717128
00717128
- Endoscopy preparation kit
The VIA procedure kit - custom includes transport pad, gauze pads, enzymatic sponge, Via basin, biohazard sticker, solidifier, lubricating jelly, DuoSwift squeegee brush, and BioGuard 4 piece kit.
US Endoscopy
00717125
00717125
- Endoscopy preparation kit