Address: 2950 Mechanic Street, Lake City, Pennsylvania 16423, USA
Phone: +1-(814)-774-2631 | Fax: +1-(814)-774-3643 | Map/Directions >>

Profile: Surgimedics manufactures smoke evacuvators. Our surgifresh mini has the same rugged construction as the plume-inator & is an ideal size for operating rooms, clinics and office settings. Our Ulpa-Clear™ disposable single use ulpa/carbon filter (Up to 1 Hour) is intended for use with PureVac™ and PureVac™ turbo smoke evacuation systems.

FDA Registration Number: 3003640911

28 Products/Services (Click for related suppliers)  
• Anti-Fog Surgical Mask with Adhesive Tape
• Cone Surgical Mask
• Endoscopic Smoke Removal Tube (FDA Code: FCZ / 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.
• Fluid-Resistant Molded Surgical Masks
• Fog-Inhibiting Surgical Masks
• In-Line Wall Suction Filters
• Latex Free Medical Tubing
• Medical Tubing Kits
• Multiple-Use In-Line Wall Filter
• Non Sterile Medical Tubing
• Non-Invasive Tubing (FDA Code: GAZ / 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).
• OEM Replacement Filters
• Single-Use In-Line Wall Filter
• Smoke Evacuation Equipment
• Smoke Pre-Filter
• Sterile Medical Tubing
• Surgical Exhaust Apparatus (FDA Code: FYD / 878.5070)
Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.
• Surgical Mask for Nurses
• Surgical Masks (FDA Code: FXX / 878.4040)
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
• Surgical Smoke Evacuators
• Tie-On Surgical Masks
• Tubing Sponge Guards
• Tubing Wands
• ULPA Filters
• ULPA Pre-Filters
• Ultra-Soft Surgical Mask for Sensitive Skin Indicator Organism Testing
• Vacuum Collection Bottle (FDA Code: KDQ / 880.6740)
• Vacuum Regulator (FDA Code: KDP / 880.6740)

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