Medical device discontinuation: N95 Mask
The N95 Mask is reported as a medical device discontinuation under subsection 62.23(2) of the Medical Devices Regulations. Updates to the status of a discontinuation can be found on the List of shortages and discontinuations webpage.
Posted on 2022-10-20
Type of report
Discontinuation
Discontinuation status
Discontinued
Name of medical device (including any component, accessory or part that is discontinued, including the model name) if applicable
N95 Mask
Other names (for example, trade name), if applicable
n/a
Package description (for example, packaging formats, sizes, quantities)
Box of 20 masks, Case of 20 boxes;
Box of 5 masks, Case of 20 boxes
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)
1570
1571
1572
Medical device licence number (for Class II, III and IV), if applicable
n/a
Authorization identification number (for devices authorized for importation or sale under an interim order made under section 30.1 of the Food and Drugs Act), if applicable
n/a
Single-use product
Yes
Importers that have reported the discontinuation (names of importers listed who have reported the discontinuation separately from the manufacturer or who are reporting on behalf of the manufacturer in a delegated capacity), if applicable
n/a
Manufacturer’s name
Dukal Corporation
Manufacturer’s mailing address
2 Fleetwood Court
Ronkonkoma, NY
United States - 11779
Reason for discontinuation
Decrease in demand for the medical device
Comments
This device was previously reported in shortage and has since been discontinued.
Footnotes
- Footnote 1
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This date reflects when a discontinuation report is first posted online. This page includes specific information related to the device that is being discontinued. Updates to the status of a discontinuation can be found on the List of shortages and discontinuations webpage.
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