Profile: Mallinckrodt manufactures and markets healthcare products in the areas of respiratory care, diagnostic imaging and prescription pharmaceuticals. Our business line comprises of contrast media & delivery systems, radio pharmaceuticals, urology imaging systems, active pharmaceutical ingredients (APIs), specialty chemicals, prescription pharmaceuticals, pulse oximeters, endotracheal tubes, tracheostomy tubes, acute care ventilation, airway management and others. Our Optivantage™ dual-head CT contrast delivery system is radio frequency identification (RFID) technology enabled, which is an automatic identification technology that captures, stores, and transmits data using RFID tags or transponders. When combined with RFID enabled Ultraject™ prefilled syringes, they prevent accidental air embolism caused from using an empty, used syringe. Our Renaissance® II spirometry system is used for diagnosing respiratory function in a variety of clinical settings. It measures a broad range of physiological parameters, provides color printout reports and has a 1,000-patient memory.
• Custom-made Curved Microscissors |
• 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. |
• Disposable Microscissors: Vertical |
• 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. |
• Drainage Bag |
• Dual-Blade Folding Knife |
• ENT Surgical Drapes (FDA Code: ERY / 878.4370) |
• Enucleation Scissors Slightly Curved |
• Eye Patch |
• Eyewash Solutions |
• Fabric-Reinforced Surgical Gowns |
• Fanny Pack |
• Featherlite Scissors |
• Floral Cutter |
• Floral Knife Curve |
• Floral Knife Straight Blade |
• Floral Shears |
• Floral Snips |
• Fluid-Resistant Surgical Gowns |
• Gastroenterographic Contrast Media |
• Gauze |
• General Purpose Surgical Drapes |
• Germicidal Wipes |
• Grape Shears |
• Heavy Duty Ratchet |
• Heavy-Duty Snap Blade Utility Knife |
• Hemostatic Control Valve |
• Hemostats (FDA Code: HRQ / 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. |
• Horizontal Curved Microscissors |
• Horizontal Scissors |
• Interventional Cardiology Surgical Drapes |
• 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. |
• Iodine Pads |
• Large Snap Blade Utility Knife |
• Latex Gloves |
• Leaded Vial Shield (FDA Code: IWW / 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. |
• Lightweight Surgical Gowns |
• Magnetic Resonance |
• Magnetic Resonance, Ferumoxsil Oral Suspension |
• Magnetic Resonance, Gadoversetamide Injection |
• Mattress Cover (FDA Code: FMW / 880.6190) A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide. |
• Mayo Tungsten Carbide Operating Scissors |
• Medical Gloves |
• Medical Procedure Trays |
• Micro Surgery Instruments, Scissors |
• Mobile Cardiac Catheterization Labs |
• Modified Castroviejo corneal scissors |
• Monopolar Laparoscopic Scissors |
• MRI Infusion Pump Systems, Infusion System Accessories |
• Neurosurgery Surgical Drapes |