Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029227324

FEI Number

3029227324

Entity Name

Philips Global Business Services LLP

City/State/Country

Baner Pune Maharashtra, IN

Establishment Address

5th Floor, Amar Madhuban Tech Park, Baner Pune Maharashtra 411045, IN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Philips Medical Systems International BV (Owner Number: 2518422)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K110293

PMA Number

N/A

All Registered Proprietary Names

Trilogy Evo Universal Ventilator Trilogy Nurse Call Adaptor Cable Nurse Call Adaptor Cable Alarm Open/Closed External Flow Sensor Assembly Adult/Pediatric OR Pediatric/Infant Nurse Call Rj9 Adapter Cable Open Dual Limb Active Exhalation Valve 12/24V Battery Cable w/terminals or adapter EverFlo EverFlo Quiet OPI and non-OPI Ultrafill Quiet Everflo Ultrafill Transfill Everflo/Everflo Q/L4 DirectView Data Management System Cough Assist T70 DirectView Data Management System Encore Anywhere A40 Heated Humidifier OMNILAB DIRECT Universal Battery Pack (UBP2) BiPAP A40 Ventilatory Support System PC Direct Omnilab Direct Omnilab Advanced/Advanced + BiPAP autoSV Advanced System One BiPAP w/ & w/o Humidifier DreamStation BiPAP autoSV w/ & w/o Humidifier DreamStation BiPAP S/T w/ & w/o Humidifier DreamStation BiPAP AVAPS w/ & w/o Humidifier V60 with PPV and Auto-Trak + ProChamber Valved Holding Chamber OptiChamber Diamond with Lite Touch mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2019-08-23
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2007-12-18
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2013-01-08
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2012-12-18
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2010-08-05
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2022-12-20
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2004-11-09
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2011-09-15

Official Correspondent

No official correspondent registered.

US Agent Details

Tom Fallon Business: Philips Email: tom.fallon@philips.com Phone: (978) 9415572

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029227324. Last updated year: 2026. Please use registration number 3029227324 when referencing this establishment in official correspondence.