VentStar Oxylog 3000f (P) 190
Catalogue number 5704964, listed by Drägerwerk AG & Co. KGaA, Germany, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Drägerwerk AG & Co. KGaA, Germany |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| 510(k) | K062267 |
| Record published | 2022-06-17 |
| Record revised | 2023-07-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5704964 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Draeger, Inc. | 510(k) number | 2016-05-31 | Class I | Device Design | Isolated episodes of leakage at the check valve were found | 42,922 units worldwide (US distribution 1,530) | 2018-03-14 |
| Draeger, Inc. | 510(k) number | 2015-12-22 | Class I | Device Design | Drager became aware of situations where the error message “Poti unplugged” was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating. | 0 | 2017-04-05 |
| Draeger, Inc. | 510(k) number | 2015-12-22 | Class I | Device Design | Drager became aware of situations where the error message “Poti unplugged” was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating. | 402 units (314 – Oxylog 3000; 88 – Oxylog 3000 Plus) | 2017-04-05 |
| Draeger Medical Systems, Inc. | 510(k) number | 2010-08-19 | Not classified | Error in labeling | Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume. | 78 potentially afftected units | 2010-11-18 |
| Draeger, Inc. | 510(k) number | 2008-10-03 | Not classified | Software design | May experience an interruption of ventilation for approximately 5 seconds | 50 units | 2009-10-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.