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HSA · registration DE0504458

Respironics AF541 EE Leak 1 Oro-Nasal Mask

SingaporeGeneral HospitalClass BRespironics, Inc.
Verified
Official record identity
Registration number
DE0504458
Model name
S AF541 EE Leak 1, 4PT HDG, INTL; M AF541 EE Leak 1, 4PT HDG, INTL; L AF541 EE Leak 1, 4PT HDG, INTL; XL AF541 EE Leak 1, 4PT HDG, INTL; S AF541 EE Leak 1, Capstrap, INTL; M AF541 EE Leak 1, Capstrap, INTL; L AF541 EE Leak 1, Capstrap, INTL; XL AF541 EE Leak 1, Capstrap, INTL; ACC, Bronchoscopy Elbow, Click Style; ACC, Bronchoscopy Elbow, Click Style; XS AF541 EE Leak 1 Under the Nose, 4PT HDG, INTL; A AF541 EE Leak 1 Under the Nose, 4PT HDG, INTL; B AF541 EE Leak 1 Under the Nose, 4PT HDG, INTL; C AF541 EE Leak 1 Under the Nose, 4PT HDG, INTL; XS AF541 EE Leak 1 Under the Nose, Capstrap, INTL; A AF541 EE Leak 1 Under the Nose, Cpastrap, INTL; B AF541 EE Leak 1 Under the Nose, Capstrap, INTL; C AF541 EE Leak 1 Under the Nose, Capstrap, INTL
Model identifier
1120920; 1120921; 1120922; 1120923; 1120925; 1120926; 1120927; 1120928; 1120984; 1121442; 1133664; 1133665; 1133666; 1133667; 1133668; 1133669; 1133670; 1133671
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 an interface for application of CPAP or bi-level therapy to patients. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) 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.