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HSA · registration DE0503176

Respironics DreamWisp Nasal Mask

SingaporeGeneral HospitalClass BRespironics, Inc.
Verified
Official record identity
Registration number
DE0503176
Model name
FitPk, DreamWisp Nsl, MED Con W/ HGR INT; P, DreamWisp Nasal Mask, Med Connector, W/HGR, INT; S, DreamWisp Nasal Mask, Med Connector, W/HGR, INT; M, DreamWisp Nasal Mask, Med Connector, W/HGR, INT; L, DreamWisp Nasal Mask, Med Connector, W/HGR, INT; XL, DreamWisp Nasal Mask, Med Connector, W/HGR, INT
Model identifier
1137921; 1137942; 1137943; 1137944; 1137945; 1137946
Registration date
May 31, 2019
Source update date
September 22, 2020
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 nasal mask is intended to provide an interface for application of Continuous Positive Airway Pressure (CPAP) or bi-level therapy to patients. The mask is intended 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.