Barnstead Harvey Hydroclave Mc10 Surgical Steam Sterilizer Autoclave Thermolyn

US $4383

Macon, Georgia, United States
Nov 3rd

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Comes with Instruction manual, 60 days return policy. This autoclave is practically new, it has been tested and functions through all cycles 100% Barnstead Harvey Hydroclave MC10 Surgical Steam Sterilizer Autoclave Thermolyne Dual voltage 115 or 230 see notes* Technical Data MC10 Cabinet Size 13-1/2" W x 16" H x 22" L (33 mm W x 406mm H x 559mm L) Chamber Size 8" diameter x 14-1/2" usable depth (203mm diameter x 368mm) Tray Sizes Two 14" x 6-1/4" x 7/8" (356mm x 135mm x 22mm) Shipping Weight 72 lbs (33 kg) Heater Wattage 1350 Watts Electrical Rating 115 VAC, 50/60 Hz, 12 Amps or 230 VAC, 50/60 Hz, 6 Amps (*See Note) Reservoir Capacity 3000 mL (approx. 3 quarts) Maximum Rated Operating Pressure 45 psi (310kPa) Environmental Conditions Operation 10° to 40°C (50° to 104°F) 30% to 70% relative humidity, non-condensing Altitude Limit 2,000 meters Storage and Transport -20° to 60°C (-4° to 140°F) 10% to 100% relative humidity Printer (Optional) 9 VAC;1 Watt (idle), 10 Watts (running) Non-Recirculating Water Accessory (Optional) Size 6-3/4" W x 13-1/2" H 15-1/4" L (171 mm W x 343mm H x 387mm L) Capacity 11.36 L (approx. 3 gallons) Reservoir Water Distilled or Low quality Deionized water (minimum 0.5 megohm/cm, maximum 1.5 megohmlcm). * Dual-voltage government models meet the requirements of IEC 11.36 L (approximately 3 gallons)- Class I, Type B equipment. Below this line is for FDA and eBay use. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- When a 510(k) is Not Required The following are examples of when a 510(k) is not required. You distribute another firm's domestically manufactured device. You may place a label on the device, "Distributed by ABC Firm" or "Manufactured for ABC Firm," (21 CFR 801.1) and sell it to end users without submission of a 510(k). In most cases, if you are a repackager or a relabeler you are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications. I would like to distribute a manufacturer's product under my own company name. Do I need to submit a 510(k)? No, the manufacture should submit the 510(k), if required for the device. As required under 21 CFR 801.1(c), where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for ABC Company," "Distributed by ABC Company," or any other wording that expresses the facts. The distributor should forward all product complaints to the manufacturer for evaluation in accordance with 21 CFR 820.198 Complaint files.