Profile: Erika De Reynosa, S.A. De C.V. specializes in offering orthopedic, prosthetic and surgical appliances & supplies. Our products include tubing clamps, catheter connectors, I.V. administration sets, single needle blood sets & accessories, and various types of blood tubing sets, transducer protectors for dialysis and peritoneal dialysis On/Off tray.
FDA Registration Number: 8030665
US Agent: Denise Oppermann / Fresenius Medical Care North America
Phone: +1-(781)-699-4479 E-Mail:
26 Products/Services (Click for related suppliers)
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• Anti-Regurgitation Valve with Blood Tubing Set (FDA Code: FJK / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer. |
• Automatic Delivery Peritoneal System (FDA Code: FKX / 876.5630) (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system. |
• Bone Clamp (FDA Code: HXD / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• Cardiopulmonary Bypass Vascular Catheter (FDA Code: DWF / 870.4210) A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. |
• Catheter Connector (FDA Code: GCD / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles. |
• Dialysis Holding Tank (FDA Code: FIN / 876.5820) |
• Dialysis Start/Stop Tray (FDA Code: FKG / 876.5820) |
• Dialysis Transducer Protector (FDA Code: FIB / 876.5820) |
• Dialyzer Reprocessing System (FDA Code: LIF / 876.5820) |
• Disposable Kidney Perfusion Kit (FDA Code: KDL / 876.5880) An isolated kidney perfusion and transport system and accesssories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set. |
• Disposable Peritoneal Dialysis Administration Kit (FDA Code: KDJ / 876.5630) |
• Hemodialysis Blood Circuit Accessories (FDA Code: KOC / 876.5820) |
• High Flux Re-Use Hemodialyzer (FDA Code: MSF / 876.5860) A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices: |
• High Permeability with/without Sealed Dialysate System (FDA Code: KDI / 876.5860) |
• Hollow Fiber Capillary Dialyzer (FDA Code: FJI / 876.5820) |
• Intravenous Administration Kit (FDA Code: FPA / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. |
• Line Clamp (FDA Code: FKK / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. |
• Liquid Hemodialysis Dialysate Concentrate Solution (FDA Code: KPO / 876.5820) |
• Low Flux Re-Use Hemodialyzer (FDA Code: MSE / 876.5820) |
• Non-Remote Conductivity Meter (FDA Code: FIZ / 876.5820) |
• Remote Type Induction Conductivity Meter (FDA Code: FLB / 876.5820) |
• Semi-Automatic Peritoneal Dialysate Delivery System (FDA Code: KPF / 876.5630) |
• Single Pass Dialysate Delivery System (FDA Code: FIL / 876.5820) |
• Single Patient Dialysate Delivery System (FDA Code: FKP / 876.5820) |
• T-Type Infusion Blood Tubing Connector (FDA Code: FKB / 876.5820) |
• Water Purification Subsystem (FDA Code: FIP / 876.5665) A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system. |