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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• Ureteral Catheter Holder (FDA Code: EYJ / 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).

• Urinals (FDA Code: FNP / 880.6730) A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.

• Urine Collection Leg Bags (FDA Code: FAQ / 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:

• Urine Leg Bags (FDA Code: FAQ / 876.5250)

• Urine Specimen Container for Drugs Of Abuse (FDA Code: MPQ / 864.3260) An over-the-counter (OTC) test sample collection system for drugs of abuse testing is a device intended to: Collect biological specimens (such as hair, urine, sweat, or saliva), outside of a medical setting and not on order of a health care professional (e.g., in the home, insurance, sports, or workplace setting); maintain the integrity of such specimens during storage and transport in order that the matter contained therein can be tested in a laboratory for the presence of drugs of abuse or their metabolites; and provide access to test results and counseling. This section does not apply to collection, transport, or laboratory testing of biological specimens for the presence of drugs of abuse or their metabolites that is performed to develop evidence for law enforcement purposes.

• Urosheath Type Incontinence Appliance (FDA Code: EXJ / 876.5250)

• Ventilator Tubing and Support Set (FDA Code: BZO / 868.5975) Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.

• Venturi Low Concentration Oxygen Mask (FDA Code: BYF / 868.5600) A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.

• Wound Exudate Absorption Hydrophilic Beads (FDA Code: KOZ / 878.4018) A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic 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.

• X-Ray Detectable Gauze (FDA Code: GDY / 878.4450) Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.