Profile: Davis And Geck Caribe, Ltd. specializes in the production of polytetrafluorethylene pledget, disposable endoscopic specimen pouch, steel sutures and umbilical tape-sterile round cotton tape.

FDA Registration Number: 9612501
US Agent: Renee Borgesano / Covidien
Phone: +1-(203)-492-5325  E-Mail:

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• Clip Removal Instrument (FDA Code: HBQ / 882.4200) A clip removal instrument is a device used to remove surgical clips from the patient.

• Clip Surgical Applier (FDA Code: GDO / 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.

• Coated Implanted Hemodialysis Catheter (FDA Code: NYU / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

• Colonic Irrigation and Aspiration Catheter (FDA Code: KDH / 876.5980) A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

• Compressible Limb Sleeve (FDA Code: JOW / 870.5800) A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

• Compression Dressing (FDA Code: MHW / 880.5075) An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

• Connecting Flexible Aspirating Tube (FDA Code: BYY / 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).

• Continuous Electronic Thermometer (FDA Code: FLL / 880.2910) A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

• Continuous Flush Catheter (FDA Code: KRA / 870.1210) A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

• Continuous Respirator Accessory (FDA Code: MOD / 868.5895) A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

• Continuous Ventilator (FDA Code: CBK / 868.5895)

• Continuous Ventilator Accessory (FDA Code: MOD / 868.5895)

• Cutaneous Electrode (FDA Code: GXY / 882.1320) A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

• Diagnostic Spirometer (FDA Code: BZG / 868.1840) A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

• Differential Ventilation Tracheal/Bronchial Tube (FDA Code: CBI / 868.5740) A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.

• Direct Patient Interface Nebulizer (FDA Code: CAF / 868.5630) A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

• Direct Patient Interface Respiratory Gas Humidifier (FDA Code: BTT / 868.5450) A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

• Disposable Hot/Cold Pack (FDA Code: IMD / 890.5710) A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

• Disposable Medical Bed (FDA Code: KME / 880.6060) Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.

• Disposable Nonelectric Urine Flow Rate Measuring Device (FDA Code: FFG / 876.1800) A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.

• Disposable Surgical Drape (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Disposable Surgical Instrument (FDA Code: KDC / 878.4800)

• Disposable Surgical Instrument Kit (FDA Code: KDD / 878.4800)

• Disposable Suture Needle (FDA Code: GAB / 878.4800)

• Double Lumen Tube for Intestinal Decompression (FDA Code: FEG / 876.5980)

• Drug Wound Dressing (FDA Code: FRO)

• Dural Sealant (FDA Code: NQR)

• Ear Oximeter (FDA Code: DPZ / 870.2710) An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

• Elastic Bandages (FDA Code: FQM / 880.5075)

• Electrocardiograph Electrode (FDA Code: DRX / 870.2360) An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

• Electroconductive Media (FDA Code: GYB / 882.1275) Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

• Electrode Cables (FDA Code: IKD / 890.1175) An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.

• Electroencephalographs (FDA Code: GWQ / 882.1400) An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

• Electronic Stethoscopes (FDA Code: DQD / 870.1875) A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

• Electrosurgical and Coagulation Unit with Accessories (FDA Code: BWA / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400)

• Electrosurgical Electrode (FDA Code: JOS / 878.4400)

• Electrosurgical Electrode Gel (FDA Code: JOT / 878.4400)

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Cleaning Accessories (FDA Code: FEB / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Endoscopic Tissue Approximation Device (FDA Code: OCW / 876.1500)

• Enema Kit (For Cleaning Purpose) (FDA Code: FCE / 876.5210) An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (876.5220).

• Enteral Infusion Pump (FDA Code: LZH / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Esophageal Airway/Obturator (FDA Code: CAO / 868.5650) An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.

• Esophageal Stethoscopes (FDA Code: BZW / 868.1910) An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.

• Extension Airway Connector (FDA Code: BZA / 868.5810) An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

• Extravascular Blood Pressure Transducer (FDA Code: DRS / 870.2850) An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

• Facility Use Minimal Ventilatory Support Continuous Ventilator (FDA Code: MNT / 868.5895)