Af531 Oronasal Ee Leak 1 Face Mask K233555 — Device overview

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Proprietary Name

AF531 Oro-Nasal EE Leak 1 Face Mask

Class 2 (Moderate Risk)

Device Name

Ventilator, Non-Continuous (Respirator)

Primary Manufacturer

Philips Electronics Ltd

Specialty

Anesthesiology

Device Information

The K Number is a unique identifier assigned by the FDA for tracking medical devices. The Regulation Number references the specific FDA regulation that governs the device, confirming its registration and compliance with FDA standards for easy regulatory verification.

Source
K Number
K233555
Unique FDA identifier
Regulation Number
868.5905
FDA regulation reference

Manufacturer Information

The Manufacturer Information section includes details about the primary manufacturer of the device, including their name and location. If applicable, it also lists the US Agent responsible for representing the manufacturer in the United States. The agent’s contact information, such as email and phone number, is provided for further communication. Additionally, the Registration Addresses section shows where the manufacturer is located worldwide and includes information about their registration status and validity, such as the Expiry Year of their registration and the establishment type (e.g., manufacturing medical devices).

Source
Primary Manufacturer
Philips Electronics Ltd
US
US Agent
Authorized U.S. representative for this device
Agent Name
Shaylee Masilunas
Contact
Email:shaylee.masilunas@philips.com
Phone:412-5423378
Agent Address
1001 Murry Ridge Lane, Ste A
Murrysville, PA 15668

Registration Addresses

2 registered establishments worldwide

Registration Name
Philips Electronics Ltd
Expiry year
2026
Registration Number
3000126629
Address
1875 Buckhorn Gate, 5th Floor
Mississauga OntarioL4W 5P1
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Registration Name
RESPIRONICS INC.
Expiry year
2026
Registration Number
2518422
Address
1001 Murry Ridge Lane
MURRYSVILLE, PA15668
Establishment Types
Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility

Owner/Operator Information

The Owner/Operator Information section provides details about the company or entity responsible for the device. It typically includes the company name of the device's owner or operator, as well as the business address, which is the primary location where the business operates or is registered. This information helps identify the entity managing or manufacturing the device and provides transparency regarding the responsible party for regulatory purposes.

Source
Company Name
Philips Medical Systems International BV
Device owner/operator
Business Address
Veenpluis 6 Best, NL-NOTA 5684PC
Primary business location