Search Results
Found 2948 results
510(k) Data Aggregation
(448 days)
Ask a specific question about this device
(246 days)
Ask a specific question about this device
(89 days)
Ask a specific question about this device
(176 days)
The Hudson RCI® Infant Dri-Tech™ Breathing Circuits are intended for neonatal, infant, and pediatric patients weighing 32kg or less in a professional healthcare environment as a conduit for warmed and humidified respiratory gases between a patient and a ventilator and includes heated wires for use with the Hudson RCI Neptune Heated Humidifier.
The Hudson RCI® Infant Dri-Tech Breathing Circuits are intended for neonatal, infant, and pediatric patients weighing 32kg or less in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier (K131912). The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
The Dri-Tech Infant Breathing Circuits are designed to be used with various patient interfaces such as oral tracheal tubes, nasal tracheal tubes, endo-bronchial tubes, and masks (for noninvasive ventilation therapies such as CPAP, BiPAP, Cannula and Mask usage). As such, Dri-Tech Breathing Circuits are designed and will be manufactured to conform to the test requirements of ISO 5367:2014 "Anaesthetic and respiratory equipment -- Breathing sets and connectors".
The dual limb configuration consists of 12mm ID inspiratory and expiratory limbs with 22mm machine side connectors that are compliant to ISO 5356-1:2015 Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets, and 12mm patient side connectors that utilize the same taper and engagement length as ISO 5356-1:2015 connectors. The infant circuits have two length configurations, a short inspiratory that is 1.12m or a long inspiratory that is 1.6m, either of which can be used with an expiratory limb that is 1.7m, and may be kitted with the accessories described below:
- Accessory Tee with Closure Cap: Optional tubing adaptor for various connections as required.
- Remote Port Tubing, 6" and 12": Unheated sections of tubing for use with incubators, isolettes, or other ambient heating to ensure the temperature probe is not heated by the environment.
- Unheated Ventilator Tubing: Required tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.
The single limb configuration is identical to the long version of the inspiratory limb of the dual limb configuration, however, is packaged with a different set of adaptors to facilitate connections and use with non-invasive therapies as described below:
- Unheated Ventilator Tubing: Optional tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.
- Pressure Monitoring Line: Optional accessory tubing for use with units without an Airway Pressure Monitor.
All Hudson RCI Dri-Tech breathing circuit configurations are packaged in polyethylene (PE) bags to protect the devices from environmental influences like dust and moisture. Included in the PE bags are additional PE bags containing ConchaSmart columns (-KIT configurations only) and included accessories. The breathing circuit PE bags are packaged ten (10) to a cardboard carton for all configurations. They are sold non-sterile.
N/A
Ask a specific question about this device
(83 days)
HyperSuture™ All Green Extension sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.
The Threadstone HyperSuture All Green Extension cables, loops, and tapes are nonabsorbable, sterile, surgical sutures composed of multiple multifilament strands of ultrahigh molecular weight polyethylene (UHMWPE) braided together to form the implant.
HyperSuture All Green Extension cables and tapes are available in 36 inches and 40 inches in length. The loop configurations are available in 24" or 2" loop configurations. HyperSuture All Green Extension cable, loops, and tape sizes include USP #2-0, USP #0, USP #1, USP #2, USP #3, USP #5, and 1.0mm tape, 1.2mm tape, 1.5mm tape, 1.8mm tape, 2.0mm tape. All variations of the suture, cables, loops, and tapes, are available with or without pre-attached needles.
N/A
Ask a specific question about this device
(30 days)
For determination of resistance to activated Protein C, caused by the Factor V:Q506 (Factor V Leiden) mutation, in plasma from untreated individuals and from patients on oral anti-coagulant (OAT) or heparin therapy.
The APC resistance phenotype is, in more than 90% of cases, due to a mutation in the Factor V gene, resulting in a replacement of Arg506 (R) with Gln (Q) in the Factor V protein. The selectivity for the Factor V:Q506 or other mutations in the Factor V gene rendering the protein resistant to inactivation by APC is increased by normalizing the concentrations of other plasma proteins involved in formation and regulation of thrombin. By performing the APTT-based APC resistance assay in the presence of an excess of Factor V Reagent Plasma, the sensitivity and specificity for the Factor V:Q506 mutation is significantly increased. Further, this modification allows for the analysis of plasma from patients who are on OAT. Sample plasma is prediluted with Factor V Reagent Plasma and incubated with the APTT reagent for a standard period of time. Coagulation is triggered by the addition of CaCl2 in the absence and presence of APC and the time of clot formation is recorded.
N/A
Ask a specific question about this device
(265 days)
The HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. These are single use, disposable device(s), provided nonsterile.
The HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, and HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor, are four-layer masks, constructed of well-known non-woven materials. Both masks are provided with earloops and a malleable nosepiece, placed within the bindings for comfort, to conform to the curvature of the wearer's nose.
N/A
Ask a specific question about this device
(112 days)
The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone, and Phencyclidine in human oral fluid at the cutoff concentrations listed below and their metabolites:
| Test | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 |
| Methadone (MTD) | Methadone | 30 |
| Methamphetamine (MET) | d-Methamphetamine | 50 |
| Opiates (OPI) | Morphine | 40 |
| Oxycodone (OXY) | Oxycodone | 20 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
The test provides only preliminary test results. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/ Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to distinguish between prescription use or abuse of the drug. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
The Healgen® Accurate Oral Fluid Drug Test is a lateral flow chromatographic immunoassay for the qualitative detection of Amphetamine, Cocaine, marijuana, Methadone, Methamphetamine, Opiates, Oxycodone and Phencyclidine in oral fluids. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
N/A
Ask a specific question about this device
(84 days)
Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eighteen models with the same IPL technology for hair removal, which is model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch.
The Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0cm2 (Model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X) and 4.2cm2 (Model DT015 Pro, DT015, DT017, DT017 Pro, DT025, DT025 Pro) that is suitable for multiple hair removal areas, such as upper lip, chin, armpits, legs, arms, bikini area, chest, back, abdomen.
The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the Hair Removal Device has the Ice-cooling function (Model: CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12) and Sapphire Ice-cooling function (Model: CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025), which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
N/A
Ask a specific question about this device
(86 days)
Holmium Laser Therapeutic Apparatus are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology,Urinary Lithotripsy, Gastroenterology,ENT, Gynecology and general surgery.
The HZ Series is a family of pulsed solid-state Holmium:YAG laser systems that deliver energy at a wavelength of 2100 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a diode-pumped Ho:YAG laser medium, and the laser energy is transmitted to the target site via SMA-905 compatible optical fibers. All models in the series share the same fundamental design and operational principles, differing in maximum average power output, Energy per pulse and frequency. The system includes a touchscreen interface, single-pedal footswitch, integrated liquid cooling, and multiple built-in safety features such as a key switch, emergency stop and door interlock, and real-time monitoring of laser output.
N/A
Ask a specific question about this device
Page 1 of 295