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The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user only.

The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts; they are intended for a single user. Both Wearable Breast Pump (Model FS12A) and Wearable Breast Pump (Model FS12B) are breast pumps 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, and auto modes and control the vacuum levels within those modes. All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are capable of providing vacuum levels from 40-160 mmHg with cycling rates from 75-133 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 21-98 cycles per minute in expression mode, and vacuum levels from 40-245 mmHg with cycling rates from 21-150 cycles per minute in auto mode. The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) 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 devices are for repeated use by a single user in a home environment. The devices are 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 devices are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

The Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The Micro Catheter is available in three inner diameters (0.017″, 0.021″ and 0.027″), and two working lengths (150cm and 155cm). All models are designed with a straight tip, and are steam shapeable by the user. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of Micro Catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter body has a semi-rigid proximal end which transitions into the flexible distal end to facilitate the advancement of the catheter in the tortuous vasculature. The Micro Catheter is compatible with ≤ 0.014″ guidewires and 5F or larger guide catheters.

The ProfojectTM Disposable Syringe and the ProfojectTM Disposable Syringe with Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The ProfojectTM Disposable Syringe is available in a sterile state. It is a single-use device comprising a polypropylene barrel with a Luer slip or Luer lock nozzle, a polypropylene plunger, and a polyisoprene rubber plunger stopper. Syringes are available in various volume specifications, ranging from 1mL to 60mL. The syringe barrel is printed with a legible graduated scale in milliliters. The syringe is compatible with U.S. legally marketed devices featuring Luer slip or Luer lock connectors that comply with ISO 80369-7. The syringe is intended for manual use only. The plunger of the syringe is pulled back to aspirate fluids or depressed to inject or expel fluids. The ProfojectTM Disposable Syringe with Needle is supplied in a sterile state. It is a single-use device comprising a Luer slip or Luer lock syringe and a hypodermic needle. The hypodermic needle consists of a stainless steel needle tube, a polypropylene needle hub, and a polypropylene needle cap. The hypodermic needle is available in variety of combinations of needle gauge (18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G) and needle length (15mm, 20mm, 25mm, 30mm, 38mm). Needle hubs are color-coded to identify the gauge of the needle tube. The Disposable Syringe with Needle is available in various combinations of syringe volume and needle size. It is intended for manual use only. The plunger of the syringe is pulled back to aspirate fluids or depressed to inject or expel fluids.