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HSA · registration DE0504457

Respironics AF541 EE Leak 2 Oro-Nasal Mask

SingaporeGeneral HospitalClass BRespironics, Inc.
Verified
Official record identity
Registration number
DE0504457
Model name
S AF541 EE Leak 2, 4PT HDG; M AF541 EE Leak 2, 4PT HDG; L AF541 EE Leak 2, 4PT HDG; XL AF541 EE Leak 2, 4PT HDG; S AF541 EE Leak 2, Capstrap; M AF541 EE Leak 2, Capstrap; L AF541 EE Leak 2, Capstrap; XL AF541 EE Leak 2,Capstrap; RP, AF541 Sizing Gauge; ACC, Bronchoscopy Elbow, Click Style; ACC, Bronchoscopy Elbow, Click Style; XS AF541 EE Leak 2 Under the Nose, 4PT HDG; A AF541 EE Leak 2 Under the Nose, 4PT HDG; B AF541 EE Leak 2 Under the Nose, 4PT HDG; C AF541 EE Leak 2 Under the Nose, 4PT HDG; XS AF541 EE Leak 2 Under the Nose, Capstrap; A AF541 EE Leak 2 Under the Nose, Capstrap; B AF541 EE Leak 2 Under the Nose, Capstrap; C AF541 EE Leak 2 Under the Nose, Capstrap
Model identifier
1120930; 1120931; 1120932; 1120933; 1120935; 1120936; 1120937; 1120938; 1120977; 1120984; 1121442; 1133672; 1133673; 1133674; 1133675; 1133676; 1133677; 1133678; 1133679
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 and single patient use in the home. 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.