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Rece International Corp.


Contact: Rene Carrasco
Address: 5881 N.W. 151st St., Ste. 111, Miami Lakes, Florida 33014, USA
Phone: +1-(305)-3626555 | Map/Directions >>
 
 

Profile: Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low concentration oxygen masks and urine leg bags. We also provide umbilical occlusion devices, topical approximation systems, scalpel blades, non dental irrigating syringes and therapeutic vaginal douche apparatus.

FDA Registration Number: 3003965134

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• Non-Sterile Closed Urine Drainage System For Non-Indwelling Catheter (FDA Code: NNZ / 876.5250)
A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:
• Non-Sterile Corrugated Rubber Sheath For Non-Indwelling Catheter (FDA Code: NNY / 876.5250)
• Non-Sterile Leg Urine Collection Bag For External Use (FDA Code: NNW / 876.5250)
• Non-Sterile Specimen Container (FDA Code: NNI / 864.3250)
A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
• Non-Sterile Urosheath Type Incontinence Device (FDA Code: NNX / 876.5250)
• Non-Surgical Isolation Gown (FDA Code: OEA / 878.4040)
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
• Non-Surgical Tongue Depressor (FDA Code: FMA / 880.6230)
A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.
• Non-Ventilatory Medicinal Nebulizer/Atomizer (FDA Code: CCQ / 868.5640)
A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.
• Nonresorbable Gauze/sponge for External Use (FDA Code: NAB / 878.4014)
A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
• Occlusive Wound Dressing (FDA Code: NAD / 878.4020)
An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
• Operating Room Scrub Brush (FDA Code: GEC / 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.
• Operating Room Shoe Cover (FDA Code: FXP / 878.4040)
• Operating Room Shoes (FDA Code: FXW / 878.4040)
• Ostomy Drainage Bag (FDA Code: FON / 876.5900)
An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.
• Oxygen Masks (FDA Code: BYG / 868.5580)
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
• Oxygen Nasal Cannula (FDA Code: CAT / 868.5340)
A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.
• Oxygen Nasal Catheter (FDA Code: BZB / 868.5350)
A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen.
• Patient Examination Gowns and Capes (FDA Code: FME / 880.6265)
An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.
• Peritoneal Catheter (FDA Code: GBW / 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.
• Personnel Protective Shield (FDA Code: KPY / 892.6500)
A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.
• Piston Syringe (FDA Code: FMF / 880.5860)
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
• Protective Apron (FDA Code: IWO / 892.6500)
• Rectal Catheter for Continent Ileostomy (FDA Code: KPH / 876.5030)
A continent ileostomy catheter is a flexible tubular device used as a form during surgery for continent ileostomy and it provides drainage after surgery. Additionally, the device may be inserted periodically by the patient for routine care to empty the ileal pouch. This generic type of device includes the rectal catheter for continent ileostomy.
• Refrigerated Centrifuges (FDA Code: JQC / 862.2050)
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
• Scalpel Blade (FDA Code: GES / 878.4800)
• Sharpes Container (FDA Code: MMK / 880.5570)
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
• Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ / 880.5200)
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570)
• Sterile Absorbent Tipped Applicator (FDA Code: KXG / 880.6025)
An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.
• Sterile Closed Urine Drainage System for Nonindwelling Catheter (FDA Code: EYZ / 876.5250)
• Sterile Corrugated Rubber Sheath For Nonindwelling Catheter (FDA Code: EYT / 876.5250)
• Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ / 876.5250)
• Sterile Specimen Container (FDA Code: FMH / 864.3250)
• Sterile Specimen Trap (FDA Code: BYZ / 880.6740)
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
• Surgical Apparel Accessories (FDA Code: LYU / 878.4040)
• Surgical Caps (FDA Code: FYF / 878.4040)
• Surgical Dress (FDA Code: FYE / 878.4040)
• Therapeutic Vaginal Douche Apparatus (FDA Code: HED / 884.5900)
A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.
• Tissue Culture Dish (FDA Code: KIZ / 864.2240)
Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.
• Tissue Culture Roller Bottle (FDA Code: KJC / 864.2240)
• Tissue Culture Tube (FDA Code: KJG / 864.3010)
Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
• Tongue Depressors (FDA Code: FMA / 880.6230)
• Tonsil Suction Tube (FDA Code: KCB / 874.4420)
• Topical Approximation System (FDA Code: MZR / 880.5240)
A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.
• Tracheal Tube Cleaning Brushes (FDA Code: EPE / 868.5795)
A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.
• Tracheal Tube Stylet (FDA Code: BSR / 868.5790)
A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
• Tracheobronchial Suction Catheter (FDA Code: BSY / 868.6810)
A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.
• Umbilical Occlusion Device (FDA Code: FOD / 880.5950)
An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
• Umbilical Scissors (FDA Code: HDJ / 884.4520)
An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:
• Ureteral Catheter Adapter (FDA Code: EYI / 876.5130)
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

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