Andersen Products, Inc.

Address: Health Science Park, 3202 Caroline Drive, Haw River, North Carolina 27258-9564, USA
Phone: +001-(800)-523-1276 | Map/Directions >>

Profile: Andersen Products, Inc. manufactures and distributes sterilizers. We are accredited with ISO 13485 and ISO 9001:2000 quality system certifications. Our sterilizers are classified as tabletop and multiload. Our Anprolene® tabletop sterilization system offers the most gentle 100% EtO sterilization cycle. It has features such as powerful ventilation & purge pumps, unique active aeration system, digital display that tracks cycle progress, a temperature sensor that monitors room conditions during each cycle, a microprocessor that monitors cycle, and an automatic restoration facility. Our EOGas series 3+ sterilization system links our unique gas diffusion technology with advanced micro-processor control. The micro-processor keeps track of the bags in the sterilizer, and the operator may load new bags or unload finished bags while others are in process. For tracking purposes, when a bag is loaded, two labels are printed; one is placed in the log book, and the other is placed in the bag. Unique multi-load capabilities eliminate batch load restrictions. The innovative unit-dose cartridges match the actual load volume, greatly reducing gas consumption.

The company was founded in 1958, has revenues of USD 5-10 Million, has ~40 employees and is ISO, CE certified.

FDA Registration Number: 1053825

48 Products/Services (Click for related suppliers)  
• Biological Sterilization Process Indicator (FDA Code: FRC / 880.2800)
A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.
• Bulk Ethylene-Oxide Sterilizer
• Cantor Gastrointestinal Decompression Tube
• Chemical Sterilization Process Indicator
• Closed Suction Drain
• Contract Laboratory
• Contract Manufacturing
• Contract Packaging
• Contract Sterilization
• Disposable Product Contract Manufacturing
• Double Lumen Tube for Intestinal Decompression (FDA Code: FEG / 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).
• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 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.
• Environmental Atmospheric Gas Monitor
• EO Gas Sterilization System
• Ethylene-Oxide Cartridge
• Ethylene-Oxide Dosimeter
• Ethylene-Oxide Gas Aerator Cabinet (FDA Code: FLI / 880.6100)
An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air.
• Ethylene-Oxide Gas Sterilizer (FDA Code: FLF / 880.6860)
An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.
• Ethylene-Oxide Leakage Detector
• Gas Recovery Equipment
• Gas Sterilization System
• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980)
• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 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.
• General Disinfectants
• Low Volume Aspirator
• Manual/Powered Portable Aspiration Pump (FDA Code: BTA / 878.4780)
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
• Medical Device, Sterilant (FDA Code: MED / 880.6885)
A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.
• Miller-Abbott Gastrointestinal Decompression Tube
• Nasogastric Tube Holder
• Nasogastric Tubes
• Nasogastric Tubes (FDA Code: BSS / 876.5980)
• Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680)
A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.
• Personal Environmental Contamination Monitor
• Pollution Control Equipment
• Radiopaque Tubing
• Silicone Penrose Drainage Tube
• Silicone T-Y Drainage Tube
• Silicone Y-Drainage Tube
• Sterilization Equipment Test
• Sterilization Packaging
• Sterilization Wrap (FDA Code: FRG / 880.6850)
A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
• Sterilization Wrap Containers (FDA Code: KCT / 880.6850)
• Sump Drain
• Suprapubic Tube Drainage (FDA Code: FFA / 876.5090)
A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.
• Table Top Ethylene-Oxide Sterilizer
• Thoracic Aspirator
• Wound Drainage Kit
• Wound Suction Pump Aspirator

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