Medical device shortage: F&P SleepStyle Auto CPAP with Modem
The F&P SleepStyle Auto CPAP with Modem is currently reported as a medical device shortage through Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. Interim Order No. 2 repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (the previous interim order) made by the Minister on March 30, 2020. For a full list of shortages, refer to the list of medical device shortages.
Posted on August 4, 2021
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
F&P SleepStyle Auto CPAP with Modem
Other names (for example trade name), if applicable
n/a
Package description (for example, packaging formats, sizes, quantities)
Package of 1
Class of medical device (I, II, III or IV), if known
Class II
Device identifier(s) (for example, serial number, catalogue number, part number, model number, or unique device identifier)
SPSAAN
Medical device licence number (for Class II, III and IV), if known
99567
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
No
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
Fisher and Paykel Healthcare Limited
Manufacturer’s name
Fisher and Paykel Healthcare Ltd.
Manufacturer’s mailing address
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland 2013
New Zealand
Reason for shortage
Increase in demand for the medical device
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