Profile: Advance Medical Designs, Inc. manufactures and distributes disposable medical devices. We supply bag decanters for the aseptic transfer of fluids from flexible containers. We are accredited with ISO 9001:2000 & ISO 13485 certification. Our products are CE marked. Our angiographic products include high pressure lines, pressure monitoring lines, fluid delivery sets, needles, closed fluid systems, angiographic waste bags and pressure dressings. Our imaging products include C-arm kovers, x-ray cassette kovers, snap kovers and snap kaps. We offer set-up kovers, drape sheets, custom kovers, camera & laser kovers.

The company was founded in 1984, has ~70 employees and is ISO 9001, CE certified.

FDA Registration Number: 1037885

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• Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP / 868.5150) An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

• Angiographic Waste Bags

• Angiographic X-Ray System (FDA Code: IZI / 892.1600) An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Bag Decanters

• Biopsy Instruments (FDA Code: KNW / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Biopsy Instruments (FDA Code: KNW / 876.1075)

• Camera Cover

• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290) A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

• Cardiovascular Trocar (FDA Code: DRC / 870.1390) A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

• Closed Fluid Systems

• Control Syringe for Precision Injections

• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570) A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

• 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 Product Contract Manufacturing

• 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.

• Drug Wound Dressing (FDA Code: FRO)

• Elastic Bandages (FDA Code: FQM / 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.

• Examination Drapes & Sheets

• 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.

• Fluid Delivery Sets

• General Diagnostic Equipment

• General Diagnostic Supplies

• General Dressings

• General Lights/Lamps

• General Medical Supplies

• General OSHA Supplies

• General Surgical Aids

• Giant Test Tubes

• High Pressure Injector Line

• High Pressure Injector Line with Rotating Adapter

• I.V. Container (FDA Code: KPE / 880.5025) An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

• I.V. Fluid Transfer Unit (FDA Code: LHI / 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.

• Image-Intensified Fluoroscopic X-Ray System (FDA Code: JAA / 892.1650) An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Intravenous Administration Kit (FDA Code: FPA / 880.5440)

• Medical First Aid Response Kit

• Non-Vented Drip Chamber

• Nursing Kit

• Ophthalmic AC-Powered Operating Microscope and Accessories (FDA Code: HRM / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

• 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.

• Pressure Monitoring Lines

• Pyrex Test Tubes

• Rimmed Glass Test Tubes

• Single Wall Introducer Needle

• Skin Pressure Protector (FDA Code: FMP / 880.6450) A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370)

• Stopcock, I.V.Set (FDA Code: FMG / 880.5440)

• Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)

• Table Operating Room Accessories (FDA Code: FWZ / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Test Tubes