Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014541700

FEI Number

3014541700

Entity Name

Philips Medical Systems Ltda

City/State/Country

Varginha Minas Gerais, BR

Establishment Address

Avenida Otto Selgado, 250, Varginha Minas Gerais CEP 37066, BR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Reusable SpO2 Sensor B800-500 BiliCal; 50 Pack 1037632 Bilichek (Advanced) 40477A Chemical/Thermal Paper M3708A Chemical/Thermal Paper M4816A Thermal Paper M2485A Chemical/Thermal Paper 989803190381 Efficia 50mm Chemical Thermal Paper, No Gridlines M4817A Thermal Paper 989803185271 Thermal Roll Paper, 110 mm Wide 989803138171 Defibrillator Chemical/Thermal Paper M3707A Chemical/Thermal Paper M2481A Chemical/Thermal Paper M1710A Chemical/Thermal Paper M2483A Chemical/Thermal Paper 40457C Chemical/Thermal Paper 989803138181 Defibrillator Chemical/Thermal Paper Disposable Adult / Pediatric SpO2 Sensor (M1131A) 15mm Male/Female Adapter CapnoTrak Airway Adapter Set Reusable Neonatal CO2 Airway Adapter Neonatal Airway Adapter Pediatric/Adult Airway Adapter NOVA DISP AIRW ADPTRADLT 20/C Neonatal/Pediatric Airway Adapter Reusable Airway Adapter MaInstream CO2 Adult Pediatric/Adult Airway Adapter with Mouthpiece 15mm Male/Female Adapter Low Deadspace AA &TRAY ASSY, ADU, ZOLL MED 8000-0262 Adapter ADU Reuse Capnostat 704-0002-00 Neonatal and Pediatric CO2 Airway Adapter, Disposable Infant Airway Adapter, Disposable Zoll Neonatal Reusable Adapter, Qty 1 Pediatric and Adult CO2 Airway Adapter, Disposable B800-11 BilEclipse, 50 Pack Carescape CO2 - LoFlo Respironics LoFlo Sidestream CO2 Module for Goldway Respironics LoFlo Sidestream CO2 Module Respironics LoFlo Sidestream CO2 Module for GE Respironics Alice, LoFlo, C5 Sidestream Module LoFlo Module - RoHS - Private Label C5 LoFlo Sidestream Module LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL Cobranded LoFlo CO2 Sampling Cannula LoFlo CO2 Sampling Cannula ADULT NASAL LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL LoFlo CO2 Sampling Cannula PEDIATRIC NASAL Sample Line-Female Luer Connector Cobranded LoFlo Sampling Line Kit Cobranded LoFlo Sampling Line Kit w/Dehumidification Tubing LoFlo SAMPLING LINE KIT LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL LoFlo Airway Adapter Kit ADULT/PEDIATRIC LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL LoFlo Airway Adapter Kit INFANT/NEONATAL LoFlo SAMPLING LINE KIT w/Dehumidification Tubing LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL M1134A Adhesive-free Neo/Inf/Adult SpO2 Sensor Neonatal / Infant / Adult Disposable SpO2 Sensor (M1133A) Infant Disposable SpO2 Sensor (M1132A) IntelliVue Patient Monitor 6500 IntelliVue Patient Monitor 6100 IntelliVue Patient Monitor 6300 989803205391 Philips Nasal Alar SpO2 Sensor 989803205381 Philips Nasal Alar SpO2 Sensor 989803205401 Philips Nasal Alar SpO2 Sensor SpO2 Sensor M1872S Neonatal Soft Single-Patient Cuff Size#4 989803167551 Neonatal Soft Single-Patient NIBP Cuffs M1868S Neonatal Soft Single-Patient Cuff Size#2 M1866S Neonatal Soft Single-Patient Cuff Size#1 M1872B Neonatal Single-Patient Cuff Size #4 M1873S Infant Soft Single-Patient Cuff Size #5 M1866B Neonatal Single-Patient Cuff Size #1 989803167541 Neonatal Single-Patient NIBP Cuffs M1868B Neonatal Single-Patient Cuff Size #2 M1870S Neonatal Soft Single-Patient Cuff Size#3 M1873B Infant Single-Patient Cuff Size #5 M1870B Neonatal Single-Patient Cuff Size #3 Patient Monitor Capnostat 5 Mainstream CO2 Sensor for Mindray Medical Capnostat 5 Mainstream CO2 Sensor for Goldway Medical Capnostat 5 Mainstream CO2 Sensor Capnography Sensor, Reusable M4602A Reusable Abdominal Belt- 60mm Wd,1.3M Lg M4603A Reusable Abdominal Belt- 60mm Wd, 15M LG M4601A Reusable Leg Belt- 32mm X 15M M2208A Disposable abdominal belts,100/cs M1562B Reusable abdominal/leg belt- 50mm X 1.3M Pediatric / Adult Combined CO2/Flow Sensor Series 3 CO2/Flow Sensor Neonatal Neonatal Flow Sensor Series 3 Pediatric/Adult Flow Sensor Series 3 Standard Size NICO Sensor Small Size NICO Sensor Pediatric Combined CO2/Flow Sensor Series 3 Neonatal Combined CO2/Flow Sensor Series 3 CO2/Flow Sensor Adult Large Size NICO Sensor CO2/Flow Sensor Pediatric

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-02-19
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2008-04-16
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	1992-10-13
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-02-24
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2003-11-10
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-01-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-05-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-04-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-02-24
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2025-09-05
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-09-05
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2025-09-05
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2025-09-05
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-09-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-09-05
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2025-09-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-09-05
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2025-09-05
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2025-09-05
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2025-09-05
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-09-05
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2025-09-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-10-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-02-19
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2011-06-09
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2009-10-29
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-05-21
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2009-10-29
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2014-09-11

Official Correspondent

No official correspondent registered.

US Agent Details

Deborah Currlin Business: PHILIPS Email: deborah.currlin@philips.com Phone: (858) 9452753

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
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3014652024	CEA GROUP INTERNATIONAL CO.,LTD	Wenzhou Zhejiang, CN
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3013250653	MASIMO CORPORATION	Irvine, CA, US
3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014541700. Last updated year: 2026. Please use registration number 3014541700 when referencing this establishment in official correspondence.