WebOwens & Minor Halyard, Inc Angela L. Bunn, RAC Director, Regulatory Affairs, Products Division 5405 Windward Parkway Alpharetta, GA 30004 Re: K181959 Trade/Device Name: HALYARD SMART-FOLD* Sterilization Wrap (Models: H450, H650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Web• Do not use wrap in dry heat or radiation sterilization methods. • Do not use wrap if damage or extraneous matter is detected prior to use. • Do not use wrapped contents if wrap is torn, wet, or compressed. PRECAUTIONS • Do not open case or package with a sharp knife. Knives can easily cut the wrap.
Director, Regulatory Affairs, Products Division 5405 Windward …
WebBefore Use Instructions o Wrap should be stored in the following temperature and humidity settings for at least two hours o Temperature between 68ºF - 73ºF / 20ºC - 23ºC o Relative Humidity between 30% - 60% o Visibly inspect wrap sheets for damage or particulates and discard if necessary. WebSep 19, 2024 · The H100 can support a tray weight of 0-3 lbs. And they’re meant for use with light linen packs, linen gowns, towel packs, single basins and other lighter wrapping needs. And the Halyard Quick Check Sterilization Wraps are available for purchase in the following sizes: 12″ x 12″. 15” x 15”. 18” x 18”. 24” x 24”. smurfs happy meal toys 2011
HALYARD Sequential Sterilization Wrap, Meets NFPA Class 1, …
Web301 Moved Permanently. nginx WebSMART-FOLD* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: Pre-vacuum steam at 270°F/132°C for 4 minutes - the wrap was validated for a dry time of 30 minutes, 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/ 55ºC and 40% – 80% ... WebSecure the bag: Use autoclave tape to seal the bag closed, making sure that the tape covers all seams and edges of the bag. Label the bag: Use a permanent marker to label the bag with the date and contents. This is important for tracking the sterilization process and ensuring that the instruments are not used past their recommended shelf life. smurf shelf