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HSA · registration DE0504456

Respironics AF541 SE Oro-Nasal Mask

SingaporeGeneral HospitalClass BRespironics, Inc.
Verified
Official record identity
Registration number
DE0504456
Model name
S AF541 SE, 4PT HDG; M AF541 SE, 4PT HDG; L AF541 SE, 4PT HDG; XL AF541 SE, 4PT HDG; S AF541 SE, Capstrap; M AF541 SE, Capstrap; L AF541 SE, Capstrap; XL AF541 SE, Capstrap; ACC, Bronchoscopy Elbow, Click Style; ACC, Bronchoscopy Elbow, Click Style; XS AF541 SE Under the Nose, 4PT HDG; A AF541 SE Under the Nose, 4PT HDG; B AF541 SE Under the Nose, 4PT HDG; C AF541 SE Under the Nose, 4PT HDG; XS AF541 SE Under the Nose, CapStrap; A AF541 SE Under the Nose, Capstrap; B AF541 SE Under the Nose, Capstrap; C AF541 SE Under the Nose, Capstrap
Model identifier
1120940; 1120941; 1120942; 1120943; 1120945; 1120946; 1120947; 1120948; 1120984; 1121442; 1133680; 1133681; 1133682; 1133683; 1133684; 1133685; 1133686; 1133687
Registration date
May 12, 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 mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

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.