FDA Device Registration & Listing · Lithia Spgs, GA, US · Registration 3011205710
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2021-01-12 |
| NOU | Continuous, Ventilator, Home Use | Anesthesiology | Class 2 | 868.5895 | 2016-07-18 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2016-07-18 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2018-06-20 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2010-08-19 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2014-05-13 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2014-05-13 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2018-07-11 |
| BYX | Tubing, Pressure And Accessories | Anesthesiology | Class 1 | 868.5860 | 2007-01-25 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2014-06-18 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2016-05-15 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Anesthesiology | Class 2 | 868.5895 | 2013-03-24 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2014-08-04 |
| CAW | Generator, Oxygen, Portable | Anesthesiology | Class 2 | 868.5440 | 2016-11-14 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3017684630 | ResMed Asia Pte. Ltd. | Singapore South West, SG |
| 3007009701 | ResMed West Coast Warehouse | Moreno Valley, CA, US |
| 3007573469 | RESMED CORP | San Diego, CA, US |
| 3038236812 | ResMed Malaysia Operations Sdn Bhd | Senai Johor, MY |
| 3030970580 | RMO | Johor Bahru, MY |
| 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 |
| 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 |
| 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 |
3011205710 when referencing this establishment in official correspondence.