Medical device shortage: Isolator Plus N95 Particulate Respirator

The Isolator Plus N95 Particulate Respirator is currently reported as a medical device shortage through the Interim Order to help prevent or alleviate shortages in relation to COVID-19. For a full list of shortages, refer to the medical device shortages: list of shortages.

Posted on 2020-04-26

• Type of report

  Actual medical device shortage

• Name of medical device (including any component, accessory, consumable material or part that is in shortage, including the model name) if applicable

  Isolator™ Plus N95 Particulate Respirator

• Other names (for example trade name), if applicable

  N/A

• Package description (for example, packaging formats, sizes, quantities)

  There are (28) masks per box, and (6) boxes per case, for a total of 168 masks per case

• Class of medical device (I, II, III or IV), if known

  Class I

• Device identifier(s) (for example, serial number, catalogue number, part number, model number, or unique device identifier)

  UDI#: 10732224000524
  Model # GPRN95

• Medical device licence number (for Class II, III and IV), if known

  N/A

• Single use product

  Yes

• Importers that have reported the shortage (Names of importers listed who have reported the shortage separately from the manufacturer or who are reporting on behalf of the manufacturer in a delegated capacity), if applicable

  Quality Footcare Products Ltd.

• Manufacturer's name

  Crosstex International, Inc.

• Manufacturer's mailing address

  10 Ranick Road
  Hauppauge, New York 11788
  USA

• Reason for shortage

  • Increase in demand for the medical device