Search Results

Ask a specific question about this device

Ask a specific question about this device

The Willow 24 Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Like the predicate device, the Willow 24 Guidewire is a single-use product with a shapeable tip, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The Willow 24 Guidewire comes in two stiffness profiles: Soft and Standard.

N/A

Ask a specific question about this device

The WEBEST Multi-Drug Urine Cup is a rapid lateral flow immunoassays for the qualitative detection of D-Amphetamine, Butalbital, Buprenorphine, Oxazepam, Benzoylecgonine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Fentanyl, Methylenedioxymethamphetamine, D-Methamphetamine, Methadone, 6-Monoacetylmorphine, Norfentanyl, Morphine, Oxycodone, Phencyclidine, D-Propoxyphene, Nortriptyline, 11-nor-Δ9-THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The single or multi-test cup can consist of up to nineteen (19) of the above listed analytes in any combination with or without on-board adulteration/ specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Webest Home Multi-Drug Urine Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below:

This is not a screening device to monitor prescription medication.

The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device.

This device provides only a preliminary test result. A more specific alternate method shall be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.

Webest Multi-Drug Urine Cup and Webest Home Multi-Drug Urine Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

N/A

Ask a specific question about this device

Water-based lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Water-based lubricant is a non-sterile, water-based personal lubricant for penile, anal and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Its formulation consists of purified water, 1,3-butanediol, propylene glycol, carbomer, glycerin, sodium hyaluronate, hydroxyethyl cellulose, sodium benzoate, sodium polyacrylate, citric acid, menthol, essence, and octyl hydroxamic acid.

N/A

Ask a specific question about this device

The Wearable Breast Pump (Model W2) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Wearable Breast Pump (Model W2) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; it is intended for a single user. The Wearable Breast Pump (Model W2) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of these pumps include: pump, valve, control board, and milk collector. The user interface allows the user to switch from expression and massage modes and control the vacuum levels within those modes. The Wearable Breast Pump (Model W2) also includes a 'Hot Compress' mode not associated with any vacuum pressure or cycle speed. When enabled, the flange is heated, the symbol indicating heating will light up, and the maximum temperature is ≤ 42°C.

All available modes consist of 9 vacuum levels. The Wearable Breast Pump (Model W2) is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 107-143 cycles per minute in massage mode and vacuum levels from 120-245 mmHg with cycling rates from 34-111 cycles per minute in expression mode. The Wearable Breast Pump (Model W2) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device is not in contact with the breast. All milk contacting components are compliant with 21 CFR 177.

N/A

Ask a specific question about this device

The Wrist Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of person older than twelve (12) years via non-invasive oscillometric technique in medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

Wrist Blood Pressure Monitor, model: BPM-W1VL is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.

It measures blood pressure and pulse rate through inflating cuff which rounding the wrist of patients. The BPM-W1VL is small, portable and used at home or in medical facilities environment.

The Wrist Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-W1VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD.

Principle of operation: This product uses the Oscillometric Measuring method to detect blood pressure. When the cuff is fully inflated to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate. And Wrist circumference is 13.5-21.5 cm.

N/A

Ask a specific question about this device

The Wearable Ambulatory Blood Pressure Monitor, model WBP-02A is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to measure systolic and diastolic pressure in individuals aged 12 years and older. The collected data can be transmitted to a PC via USB for healthcare professionals to review and analyze. This device is not intended for diabetic patients, pregnant women, or patients with arrhythmia. It is intended for prescription use only.

The WBP-02A Ambulatory Blood Pressure Monitor from Hingmed Medical comprises a main unit, a cuff, a USB data cable, and PC analysis software. This compact and portable device is worn comfortably on the patient's upper arm. The cuff inflates to occlude the brachial artery and then gradually deflates. The device employs the oscillometric method to measure blood pressure and pulse parameters during the deflation phase, capturing the transition from blood flow occlusion to restoration. The main unit's internal memory can store up to 300 measurement records. Upon completion of the monitoring period, the data is transferred via the USB cable to a computer for comprehensive statistical analysis using the dedicated software.

The ambulatory blood pressure monitor software has two components: embedded software and PC software.

The embedded software runs on the main control unit, directing the monitor to take measurements and collect blood pressure data, which it sends to the PC software via USB. The PC software analyzes the data, generates charts for medical review, and can also configure the device—such as setting measurement intervals—and initiate readings.

The PC software operates offline and does not replace any tasks performed by healthcare professionals.

The device firmware does not include the calculation function for Mean Arterial Pressure (MAP), and the OLED screen on the host device does not display MAP values. The accompanying PC software can display the hourly average MAP value and its trend graph. MAP is calculated using the standard equivalent formula, as follows:

Calculation Formula: MAP = (SBP + 2 x DBP) / 3
Alternative expression: MAP = DBP + (1/3) x PP

Where:

• SBP = Systolic Blood Pressure
• DBP = Diastolic Blood Pressure
• PP = Pulse Pressure (SBP – DBP)

Note on the Formula:
The expression "MAP = (SBP + 2 x DBP) / 3" is mathematically equivalent to the standard MAP formula "DBP + 1/3 x (SBP – DBP)".

N/A

Ask a specific question about this device

The Wearable Breast Pump (Model W12) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Wearable Breast Pump (Model W12) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; it is intended for a single user. The Wearable Breast Pump (Model W12) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of these pumps include: pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, auto, and massage modes and control the vacuum levels within those modes. The Wearable Breast Pump (Model W12) also includes a 'Hot Compress' mode not associated with any vacuum pressure or cycle speed. When enabled, the flange is heated, the symbol indicating heating will light up, and the maximum temperature is <= 42 degrees C.

All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model W12) is capable of providing vacuum levels from 40-150 mmHg with cycling rates from 86-127 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 34-109 cycles per minute in expression mode, vacuum levels from 40-245 mmHg with cycling rates from 34-130 cycles per minute in auto mode, and vacuum levels from 40-120 mmHg with cycling rates from 90-143 cycles per minute in massage mode. The Wearable Breast Pump (Model W12) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device is not in contact with the breast. All milk contacting components are compliant with 21 CFR 177.

N/A

Ask a specific question about this device

The Willow 18 Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Like the predicate device, the Willow 18 Guidewire is a single-use product with a shapeable tip, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The Willow 18 Guidewire comes in two stiffness profiles: Soft and Standard.

N/A

Ask a specific question about this device