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DEVICE DETAILS

NAME OF DEVICEAF531 ORO-NASAL EE FACE MASK
ESTABLISHMENT NAMEPHILIPS MALAYSIA SENDIRIAN BERHAD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB4408025-211606
BRAND NAMEPHILIPS RESPIRONICS
MEDICAL DEVICE CATEGORYMD 0100 - GENERAL NON-ACTIVE, NON-IMPLANTABLE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe AF531 Oro-Nasal EE Face Mask are devices that have only indirect clinical benefit in that they are used within device systems for the provision of non-invasive ventilation therapy. They do not, by themselves, deliver any therapeutic benefit to patients. The principles of operation and technology for the AF531 Oro-Nasal EE Face Mask have been in use for >35 years to aid treatment of sleep disordered breathing and respiratory insufficiency and failure, and the AF531 Oro-Nasal EE Face Mask detailed in this registration application have been on the market since 2008. The key difference between the Philips AF531 EE Leak 1 and EE Leak 2 elbows lies in the design of the exhalation port: EE Leak 1 (Clear) has a minimal, intentional leak, while EE Leak 2 (Orange) has a built-in leak port for use with specific circuits EE Leak 1: Features a minimal, intentional leak. Not sufficient to eliminate exhaled CO2 from the patient. EE Leak 2: Has a built-in leak port. Can be used without an additional exhalation port.
DEVICE INTENDED PURPOSEIntended Use Medium and Large Size: The AF531 Oro-Nasal EE Leak 1 and 2 Face 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 (>30 kg) for whom CPAP or bi-level therapy has been prescribed. Small Size: The AF531 Oro-Nasal EE Leak 1 & 2 Face 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 7 years or older (>20 kg) for whom CPAP or bi-level therapy has been prescribed.
VALIDITY DATE OF REGISTRATION18/09/2025 - 17/09/2030

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1AF531 Oro-Nasal, Single-Use, Capstrap Headgear, EE, Leak 1, Small, 10 pk1072627
2AF531 Oro-Nasal, Single-Use, Capstrap Headgear, EE, Leak 1, Medium, 10 pk1072628
3AF531 Oro-Nasal, Single-Use, Capstrap Headgear, EE, Leak 1, Large, 10 pk1072629
4AF531 Oro-Nasal, Single-Use, Capstrap Headgear, EE Leak 1/NE Elbow, Small, 10 pk1072636
5AF531 Oro-Nasal, Single-Use, Capstrap Headgear, EE Leak 1/NE Elbow, Medium, 10 pk1072637
6AF531 Oro-Nasal, Single-Use, Capstrap Headgear, EE Leak 1/NE Elbow, Large, 10 pk1072638
7AF531 Oro-Nasal, Single-Use, Four Point Headgear, EE, Leak 1, Small, 10 pk1072621
8AF531 Oro-Nasal, Single-Use, Four Point Headgear, EE, Leak 1, Medium, 10 pk1072622
9AF531 Oro-Nasal, Single-Use, Four Point Headgear, EE, Leak 1, Large, 10 pk1072623
10AF531 Oro-Nasal, Single-Use, Four Point Headgear, EE Leak 1/NE Elbow, Small, 10 pk1072633
11AF531 Oro-Nasal, Single-Use, Four Point Headgear, EE Leak 1/NE Elbow, Medium, 10 pk1072634
12AF531 Oro-Nasal, Single-Use, Four Point Headgear, EE Leak 1/NE Elbow, Large, 10 pk1072635
13AF531 Oro-Nasal, Single-Use, Capstrap Headgear, EE, Leak 2, Small, 10 pk1100390
14AF531 Oro-Nasal, Single-Use, Capstrap Headgear, EE, Leak 2, Medium, 10 pk1100391
15AF531 Oro-Nasal, Single-Use, Capstrap Headgear, EE, Leak 2, Large, 10 pk1100392
16AF531 Oro-Nasal, Single-Use, Four Point Headgear, EE, Leak 2, Small, 10 pk1100393
17AF531 Oro-Nasal, Single-Use, Four Point Headgear, EE, Leak 2, Medium, 10 pk1100394
18AF531 Oro-Nasal, Single-Use, Four Point Headgear, EE, Leak 2, Large, 10 pk1100395
19Philips Procedure 5 Pack, AF531 EE Leak 1 with FEP, S1072639
20Philips Procedure 5 Pack, AF531 EE Leak 1 with FEP, M1072640
21Philips Procedure 5 Pack, AF531 EE Leak 1 with FEP, L1072641
22Philips Procedure 5 Pack, AF531 EE Leak 1 with Capstrap headgear with FEP, S1072642
23Philips Procedure 5 Pack, AF531 EE Leak 1 with Capstrap headgear with FEP, M1072643
24Philips Procedure 5 Pack, AF531 EE Leak 1 with Capstrap headgear with FEP, L1072644
25EE Leak 1 entrainment elbow1072645
26EE Leak 1 entrainment elbow1072646
27EE leak 1 elbow with NIVO port1120967
28EE leak 2 elbow with NIVO port1120968
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