FDA Device Registration & Listing · Daventry Northamptonshire, GB · Registration 3023272766
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Anesthesiology | Class 2 | 868.5270 | 2022-11-16 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-11-16 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Anesthesiology | Class 2 | 868.5270 | 2022-06-23 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | Anesthesiology | Class 2 | 868.5905 | 2024-10-29 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-11-16 |
| CAW | Generator, Oxygen, Portable | Anesthesiology | Class 2 | 868.5440 | 2022-11-16 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5450 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2022-06-23 |
| IKK | System, Isokinetic Testing And Evaluation | Physical Medicine | Class 2 | 890.1925 | 2022-06-24 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5450 | 2022-06-23 |
| BYG | Mask, Oxygen | Anesthesiology | Class 1 | 868.5580 | 2022-06-24 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BWF | Spirometer, Therapeutic (Incentive) | Anesthesiology | Class 2 | 868.5690 | 2022-06-24 |
| BYI | Percussor, Powered-Electric | Anesthesiology | Class 2 | 868.5665 | 2024-10-29 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Anesthesiology | Class 2 | 868.2600 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2022-06-24 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | Anesthesiology | Class 2 | 868.1720 | 2022-06-24 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.1025 | 2022-06-24 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Anesthesiology | Class 2 | 868.5270 | 2022-06-23 |
| BZQ | Monitor, Breathing Frequency | Anesthesiology | Class 2 | 868.2375 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-11-16 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2022-06-23 |
| ISD | Exerciser, Measuring | Physical Medicine | Class 2 | 890.5360 | 2022-06-24 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-06-23 |
| BZH | Meter, Peak Flow, Spirometry | Anesthesiology | Class 2 | 868.1860 | 2022-06-23 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5450 | 2022-06-23 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2022-06-23 |
| BTI | Compressor, Air, Portable | Anesthesiology | Class 2 | 868.6250 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5450 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| NVP | Holding Chambers, Direct Patient Interface | Anesthesiology | Class 2 | 868.5630 | 2022-06-23 |
| FMP | Protector, Skin Pressure | General Hospital | Class 1 | 880.6450 | 2022-06-24 |
| BYP | Mouthpiece, Breathing | Anesthesiology | Class 1 | 868.5620 | 2022-06-24 |
| BZG | Spirometer, Diagnostic | Anesthesiology | Class 2 | 868.1840 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2022-06-23 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5450 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-11-16 |
| FOX | Stand, Infusion | General Hospital | Class 1 | 880.6990 | 2022-06-24 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Anesthesiology | Class 2 | 868.2600 | 2022-06-23 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-06-23 |
| ILQ | System, Communication, Powered | Physical Medicine | Class 2 | 890.3710 | 2022-11-16 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| OUG | Medical Device Data System | General Hospital | Class 1 | 880.6310 | 2022-06-24 |
| MNT | Sv70 Ventilator | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2025-12-11 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | Class 1 | 868.5240 | 2022-06-24 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | Anesthesiology | Class 2 | 868.1850 | 2022-06-24 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2022-06-23 |
| HCC | Device, Biofeedback | Neurology | Class 2 | 882.5050 | 2022-06-24 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2022-06-23 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-06-23 |
| BZC | Calculator, Pulmonary Function Data | Anesthesiology | Class 2 | 868.1880 | 2024-10-15 |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | Anesthesiology | Class 2 | 868.5935 | 2022-06-23 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2022-11-16 |
| GWQ | Full-Montage Standard Electroencephalograph | Neurology | Class 2 | 882.1400 | 2022-06-23 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2022-06-23 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2022-06-23 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2022-06-23 |
| SDT | Intra-Pulmonary Percussive Vibration (Ipv) Devices | Anesthesiology | Class 2 | 868.5665 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2025-12-11 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2022-06-24 |
| LRK | Device, Anti-Snoring | Dental | Class 2 | 872.5570 | 2022-06-23 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2022-06-24 |
| NXQ | Reminder, Medication | Physical Medicine | Class 1 | 890.5050 | 2022-06-24 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| GWQ | Full-Montage Standard Electroencephalograph | Neurology | Class 2 | 882.1400 | 2022-06-23 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | Neurology | Class 2 | 882.1400 | 2025-12-11 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-11-16 |
| NOU | Continuous, Ventilator, Home Use | Anesthesiology | Class 2 | 868.5895 | 2022-11-16 |
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | Clinical Chemistry | Class 1 | 862.1113 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| NOU | Continuous, Ventilator, Home Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2022-06-24 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | Anesthesiology | Class 2 | 868.1850 | 2022-06-24 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.1025 | 2022-06-24 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5450 | 2022-06-23 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2022-06-24 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5450 | 2022-06-23 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | Anesthesiology | Class 1 | 868.5975 | 2022-06-24 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2022-06-23 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | Anesthesiology | Class 2 | 868.5905 | 2024-10-29 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-24 |
| BWF | Spirometer, Therapeutic (Incentive) | Anesthesiology | Class 2 | 868.5690 | 2022-06-23 |
| BYX | Tubing, Pressure And Accessories | Anesthesiology | Class 1 | 868.5860 | 2022-06-24 |
| BTK | Strap, Head, Gas Mask | Anesthesiology | Class 1 | 868.5560 | 2022-06-24 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2022-11-16 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| NOU | Continuous, Ventilator, Home Use | Anesthesiology | Class 2 | 868.5895 | 2024-10-15 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2024-10-15 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2024-10-15 |
| MNT | Sv70 Ventilator | Anesthesiology | Class 2 | 868.5895 | 2024-10-15 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2024-10-15 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-24 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-06-24 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2024-10-17 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-24 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2025-12-11 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2022-06-23 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | Anesthesiology | Class 2 | 868.1850 | 2022-06-24 |
| CAW | Generator, Oxygen, Portable | Anesthesiology | Class 2 | 868.5440 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2025-12-11 |
| MNT | Sv70 Ventilator | Anesthesiology | Class 2 | 868.5895 | 2025-12-11 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | Neurology | Class 2 | 882.1400 | 2025-12-11 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2025-12-11 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2025-12-11 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2025-12-11 |
| NOU | Continuous, Ventilator, Home Use | Anesthesiology | Class 2 | 868.5895 | 2025-12-11 |
| CAW | Generator, Oxygen, Portable | Anesthesiology | Class 2 | 868.5440 | 2025-12-11 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2022-06-24 |
| BZG | Spirometer, Diagnostic | Anesthesiology | Class 2 | 868.1840 | 2022-06-23 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2022-06-23 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| BYH | Drain, Tee (Water Trap) | Anesthesiology | Class 1 | 868.5995 | 2022-06-24 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.1025 | 2022-06-24 |
| BZH | Meter, Peak Flow, Spirometry | Anesthesiology | Class 2 | 868.1860 | 2022-06-23 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2022-06-23 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | Anesthesiology | Class 2 | 868.5965 | 2024-10-15 |
| BXP | Transducer, Gas Flow | Anesthesiology | Class 1 | 868.2885 | 2022-06-24 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-06-23 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| 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 |
| K033276 | Resmed, Ltd. | VPAP III ST-A | 2004-06-07 |
| K051895 | Datex-Ohmeda, Inc. | GE DATEX-OHMEDA ENGSTROM CARESTATION | 2005-09-27 |
| 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-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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3012667060 | HMC Premedical S.p.A. | Medolla Modena, IT |
| 3013505405 | BMC (Tianjin) Medical Co., Ltd. | Wuqing District Tianjin, CN |
| 3033530343 | BMC INVESTMENT HOLDING LIMITED | Hong Kong, HK |
| 3017684630 | ResMed Asia Pte. Ltd. | Singapore South West, SG |
| 3042507287 | 3B MEDICAL INC | W Jefferson, OH, US |
3023272766 when referencing this establishment in official correspondence.