WebCelerity HP Incubator . February 8, 2024 Page 2 of 7 . 1. Device Name. Trade Name: Celerity HP Incubator Common/usual Name: Incubator/Reader (accessory to Biological Indicator) Device Classification: Class II Classification Name: Indicator, Biological Sterilization Process (21 CFR 880.2800, FRC) 2. Predicate Device. K171587 - VERIFY ® WebCelerity™ 20 HP Biological Indicator and HP Incubator allow you to standardise your process with a BI for all your Vaporized Hydrogen Peroxide sterilizers. The Celerity HP Incubator is designed to incubate and automatically read the Celerity™ 20 HP Biological Indicator (BI) at 57°C (135°F) for a fluorescent result within 20 minutes.
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WebCelerity™ 20 HP Biological Indicators are single-use biological indicators designed to monitor both V-PRO Low Temperature Sterilization Systems and STERRAD Models*, … WebCELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack: Applicant: STERIS Corporation: 5960 Heisley Rd: Mentor, OH 44060 Applicant Contact: Anthony Piotrkowski: Correspondent: STERIS Corporation: 5960 Heisley Rd: Mentor, OH 44060 Correspondent Contact: Anthony Piotrkowski: Regulation Number ... common social effects of breast cancer
Anthony Piotrkowski 5960 Heisley Rd Regulation Number: 21 …
WebCELERITY 20 HP Biological Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a … WebFeature Celerity. Subject Device . UniversalBiological . Indicator Incubator (K213881) Predicate Device . 20 HP Indicator (K190297) Comparison . Indications for Use . Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a WebBiological & Chemical Indicators Biological Indicators for Sterilization. Chemical Indicators for Sterilization. Decontamination Equipment VHP Sterilization and Biodecontamination Products. Therapeutic Endoscopy Endoscopy Devices GI Bleed Management and Irrigation Devices. Enteroscopy & Capsule Delivery Devices ducati scrambler bicycle