CEVA LOGISTICS NETHERLANDS BV (Venray)

FDA Device Registration & Listing · Oostrum Limburgh, NL · Registration 3018783526

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018783526
FEI Number
3018783526
Entity Name
CEVA LOGISTICS NETHERLANDS BV (Venray)
City/State/Country
Oostrum Limburgh, NL
Establishment Address
Edisonstraat 2-6, Oostrum Limburgh 5807 GG, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
CEVA Logistics Netherlands BV (Owner Number: 10086416)
Owner / Operator Contact Address
Edisonstraat 10-12, Oostrum LB, NL-NOTA 5807 GG, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL; Neonatal Flow and CO2 Sensor, Disposable; Proximal Flow Sensor, Neonatal Neonatal Flow and CO2 Sensor, Disposable CapnoTrak Dehumidification Tubing; Dehumidification Tubing - 1 ft.; Pediatric and Adult CO2 Airway Adapter, Reusable LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL; Neonatal and Pediatric CO2 Airway Adapter, Reusable; Proximal Flow Sensor, Neonatal PEDI NASAL/ORAL CO2 CANULA CAPNOFLEX CapnoTrak CO2 Nasal Cannula ; Cannula Nasal/Oral CO2 Adult Capnoflex SAMPLING LINE MALE LUER-LOK ADAPTER DEH Cannula Nasal CO2 Adult Capnoflex; Cannula Nasal CO2 Ped Capnoflex LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL; Delivery Cannula INFANT/NEONATAL NASAL; INFANT NASAL CO2/O2 CANNULA CapnoTrak CO2/O2 Nasal Cannula ; CapnoTrak O2 Delivery Extension Line; LoFlo CO2 Sampling Cannula ADULT NASAL; CapnoTrak CO2/O2 Oral Nasal Cannula LoFlo CO2 Sampling Cannula PEDIATRIC NASAL; CapnoTrak CO2 Oral Nasal Cannula; PEDI NASAL/ORAL CO2 CANNULA CAPNOFLEX INFANT NASAL CO2 CANNULA CAPNOFLEX LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL Sample LIne Male Luer Capnoflex Nasal Cannula; AC611 High Flow Nasal Cannula; Cannula Nasal/Oral CO2/O2 Adu Capnoflex LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL; CapnoTrak CO2 Sampling Extension Line; CapnoTrak Water Filter Assembly; Nasal Cannula; Cannula Nasal CO2/O2 Adult Capnoflex; Cannula Nasal CO2/O2 Ped Capnoflex LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL; Sidestream Reusable Neb and Masks Therapy Mask 3100 NC/SP Disposable 15mm MPV circuit Disposable 22mm non-heated passive and heated active circuits Disposable 15 mm non-heated passive and heated active circuits Lifeline Personal Response System Communicator, autoalert help button, mobile help button, personal help button, handse Philips PED INF Airway Adapter Philips ADU PED A ADPTR W Humid, M2772A Philips ADU Oral Nasal CO2 Can, M2756A Philips ADU Nasal CO2 Cannula, M2744A Philips PED Oral Nas CO2 O2 Can, M2761A Philips ADU Oral Nas CO2 O2 Can, M2760A Philips PED INF A ADPTR W HUMID, M2773A Philips Sample Line Kit, M2776A CO2 Nasal Cannula - Infant Philips INF Nasal CO2 O2 Cannula Philips PED Oral Nasal CO2 Can, M2757A Philips ADU PED Airway Adapter, M2768A Philips Sample Line W HUMID Kit, M2777A Philips PED Nasal CO2 O2 Cannula, M2751A IntelliVue Patient Monitors Philips ADU Nasal CO2 O2 Cannula, M2750A Mask Cushion Adhesive (AF531) Philips NM3 Respiratory Monitor w/VentAssist Disposable Angled Mouthpiece Mouthpiece Straight Reusable Mouthpiece Mouthpiece, Angled Pegaso V Sleepmapper (RIMR) HL7 Interface Utility (RIMR) DreamStation Cellular Modem (RIST) AOM (RIMR) Payer Integration Software (RIMR); PR1 Wired/Wireless Modems (RIST) Payer Integration Software (RIMR) Omnilab Conncect (RIMR) DreamStation Link Module (RIST) DreamStation Wi-Fi Accessory (RIST Encore Basic (RIMR) Airway Adapter - Single Patient Use - Neonatal CAPNOSTAT 5 Mainstream Sensor, Maquet Airway Adapter - Single Patient Use - Adult/Pediatric; Reusable Adult/Pediatric Airway Adapter ADULT AIRWAY ADAPTER, QTY 1, MAQUET Innospire Essence Innospire Elegance Therapy Mask 3100 NC/SP Innospire Essence Innospire Elegance Innospire Go I-neb TIM/General Purpose ADULT AIRWAY ADAPTER, QTY 1, MAQUET Airway Adapter - Single Patient Use - Neonatal Reusable Adult/Pediatric Airway Adapter Airway Adapter - Single Patient Use - Adult/Pediatric Rapid Actigraphy Data Analyzer Service Actiware Actiwatch Spectrum Pro/Plus Actiwatch Spectrum Pro/Plus + Dock Peak Flow Meter Asthma Check Asthma Mentor Wisp Nasal Mask Wisp SE Nasal Mask LiquiCell CPAP Cushions NIVO or NIVO Pro Nebulizer NIVO Pro Nebulizer w/EE or SE Elbow NM3 Respiratory Profile Monitor System 22 Aerosol Mask Threshold Pep CAPNOSTAT 5 Mainstream CO2 sensor FloTrak Elite Module wI Capnostat 5 C02 Sensor Drain, Tee (water trap) Pediatric Combined CO2/Flow Sensor Series 3 Neonatal Flow Sensor Series 3 CO2/Flow Sensor Adult; Neonatal Combined CO2/Flow Sensor Series 3 CO2/Flow Sensor Pediatric CO2/Flow Sensor Neonatal Pediatric / Adult Combined CO2/Flow Sensor Series 3 Pediatric/Adult Flow Sensor Series 3 Performance Tubing; Oxygen Manifold Kit Low Range Cabinet Flow Meter SmartSleep, Deep Sleep Headband Respironics LoFlo Sidestream CO2 Module Respironics Alice, LoFlo, C5 Sidestream Module Respironics LoFlo Sidestream CO2 Module for GE Carescape CO2 - LoFlo C5 LoFlo Sidestream Module; LoFlo Module - RoHS - Private Label Respironics LoFlo Sidestream CO2 Module for Goldway Capnography Sensor, Reusable Capnostat 5 Mainstream CO2 Sensor Capnostat 5 Mainstream CO2 Sensor for Mindray Medical Capnostat 5 Mainstream CO2 Sensor for Goldway Medical Headgear Chin Strap Flow Sensor FloTrak CO2 Sensor Single-Patient Use Adult Airway Adapte Single-Patient Use Adult Airway Adapter Reusable NEO Airway Adapter, Philip IntelliVue Patient Monito Reusable ADU-PED Airway Adapter, Philips Mainstream CO2 Sensor M3014A Capnography Extension Patient Circuits Sidestream Reusable Neb and Masks

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2022-11-08
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-08
NHJ Device, Positive Pressure Breathing, Intermittent Anesthesiology Class 2 868.5905 2022-11-08
BWF Spirometer, Therapeutic (Incentive) Anesthesiology Class 2 868.5690 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2022-11-08
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-09
NVP Holding Chambers, Direct Patient Interface Anesthesiology Class 2 868.5630 2022-11-09
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-11-08
ILQ System, Communication, Powered Physical Medicine Class 2 890.3710 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2025-12-11
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-11-09
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2022-11-08
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-11-08
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-11-08
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2022-11-09
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-08
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2022-11-08
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass) Anesthesiology Class 2 868.5935 2024-10-23
OUG Medical Device Data System General Hospital Class 1 880.6310 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-09
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-11-09
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2022-11-08
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-11-08
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-09
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-08
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2022-11-08
SDT Intra-Pulmonary Percussive Vibration (Ipv) Devices Anesthesiology Class 2 868.5665 2022-11-08
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-11-08
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2022-11-08
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-09
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-11-08
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-08
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2022-11-08
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-11-08
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-09
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-10-21
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2022-11-08
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-09
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2022-11-08
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
IKK System, Isokinetic Testing And Evaluation Physical Medicine Class 2 890.1925 2022-11-08
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-11-08
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2022-11-09
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2025-12-11
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2025-12-11
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2025-12-11
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2025-12-11
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2025-12-11
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2022-11-08
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-09
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2022-11-08
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2022-11-09
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-08
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2022-11-09
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BWF Spirometer, Therapeutic (Incentive) Anesthesiology Class 2 868.5690 2022-11-08
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-11-08
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2022-11-09
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-09
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-11-09
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2022-11-09
BYH Drain, Tee (Water Trap) Anesthesiology Class 1 868.5995 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BXP Transducer, Gas Flow Anesthesiology Class 1 868.2885 2022-11-09
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2022-11-08
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2022-11-08
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-08
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2025-12-10
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2025-12-10
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2025-12-10
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2025-12-10
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2025-12-10
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2025-12-10
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2025-12-10
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2025-12-10
HCC Device, Biofeedback Neurology Class 2 882.5050 2022-11-08
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2022-11-08
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-11-09
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-08
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2022-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2024-10-21
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-11-09
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-11-08
MYB Pillow, Cervical (For Mild Sleep Apnea) Dental Class 2 872.5570 2022-11-08
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2024-10-21
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
BYI Percussor, Powered-Electric Anesthesiology Class 2 868.5665 2024-10-23
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2022-11-09
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2022-11-09
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2022-11-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-11-08
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-11-09
NHJ Device, Positive Pressure Breathing, Intermittent Anesthesiology Class 2 868.5905 2022-11-08
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2022-11-09
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2022-11-08
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-11-08
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2022-11-08
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2024-10-21
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-11-08
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2022-11-08
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2022-11-08
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2022-11-08
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2022-11-09

Official Correspondent

No official correspondent registered.

US Agent Details

Kay Knox Business: Kay E Knox Email: kay.knox@cevalogistics.com Phone: (614) 4895164

Related Public Records

Same Entity

CEVA Logistics Netherlands BV
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07
K792722 Novametrix Medical Systems, Inc. NOVAMETRIX CPAP NASAL CANNULA 1980-01-24
K082979 Resmed, Ltd. S8 ADVANCE 2009-01-02
K203126 Resmed Pty , Ltd. S10 Kirra 2020-12-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2020 TELEFLEX-MORRISVILLE 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0031-2026 Percussionaire Corporation 1
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018783526. Last updated year: 2026. Please use registration number 3018783526 when referencing this establishment in official correspondence.
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