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HSA · registration DE0506546

Respironics DreamWear Silicone Pillows Mask

SingaporeGeneral HospitalClass BRespironics, Inc.
Verified
Official record identity
Registration number
DE0506546
Model name
S, DreamWear Silicone Pillows, Small Frame with Headgear, Global; M, DreamWear Silicone Pillows, Small Frame with Headgear, Global; L, DreamWear Silicone Pillows, Small Frame with Headgear, Global; MW, DreamWear Silicone Pillows, Small Frame with Headgear, Global; S, DreamWear Silicone Pillows, Medium Frame with Headgear, Global; M, DreamWear Silicone Pillows, Medium Frame with Headgear, Global; L, DreamWear Silicone Pillows, Medium Frame with Headgear, Global; MW, DreamWear Silicone Pillows, Medium Frame with Headgear, Global; S, DreamWear Silicone Pillows, Large Frame with Headgear, Global; M, DreamWear Silicone Pillows, Large Frame with Headgear, Global; L, DreamWear Silicone Pillows, Large Frame with Headgear, Global; MW, DreamWear Silicone Pillows, Large Frame with Headgear, Global; S, DreamWear Silicone Pillows, Small Frame without Headgear, Global; M, DreamWear Silicone Pillows, Small Frame without Headgear, Global; L, DreamWear Silicone Pillows, Small Frame without Headgear, Global; MW, DreamWear Silicone Pillows, Small Frame without Headgear, Global; S, DreamWear Silicone Pillows, Medium Frame without Headgear, Global; M, DreamWear Silicone Pillows, Medium Frame without Headgear, Global; L, DreamWear Silicone Pillows, Medium Frame without Headgear, Global; MW, DreamWear Silicone Pillows, Medium Frame without Headgear, Global; S, DreamWear Silicone Pillows, Large Frame without Headgear, Global; M, DreamWear Silicone Pillows, Large Frame without Headgear, Global; L, DreamWear Silicone Pillows, Large Frame without Headgear, Global; MW, DreamWear Silicone Pillows, Large Frame without Headgear, Global; DreamWear Silicone Pillows, FitPack, Global; DreamWear Silicone Pillows, Setup Pack; DreamWear Silicone Pillows, Demo Pack
Model identifier
1146410; 1146411; 1146412; 1146413; 1146414; 1146415; 1146416; 1146417; 1146448; 1146449; 1146450; 1146451; 1146453; 1146454; 1146455; 1146456; 1146457; 1146458; 1146459; 1146460; 1146461; 1146462; 1146463; 1146464; 1146468; 1146470; 1146471
Registration date
January 03, 2022
Classification
Risk class
Class B
Official value: CLASS B
Published category
General Hospital
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Published parties
Product owner
Respironics, Inc.
Registrant / registration holder
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Official description

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66 lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Additional source fields
Product owner address
1001 Murry Ridge Lane, Murrysville, PA 15668, United States
Registrant address
622 LORONG 1 TOA PAYOH, Singapore 319763
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.