Trilogy
Trilogy Evo Ventilator System with Oxygen Blending Module, Iberia Spain
70manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (46), Jiangsu (7), Beijing (5). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Beijing Kingst Commercial & Trade Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Showing 12 of 70. All 70 manufacturers in China registered for Oximeter
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083526 |
| Record published | 2020-02-26 |
| Record revised | 2021-02-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -4 to 140 °F; Storage environment humidity 15 to 95 % RH |
| Distribution end date | 2021-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R1054096B | In distribution | |
| Trilogy100 Ventilator, Germany | In distribution | |
| Trilogy200 Ventilator, Australia | In distribution | |
| Trilogy 202 Ventilator, Canada | In distribution | |
| Trilogy100 Ventilator, Latin America | In distribution | |
| Trilogy Evo Ventilator with oxygen blending model, Iberia | In distribution | |
| Trilogy100 Ventilator, International | In distribution | |
| U1054096B | In distribution | |
| RTO1054260B | In distribution | |
| R1054097B | In distribution | |
| 00 | In distribution | |
| Trilogy 202 Ventilator, United States | In distribution | |
| Trilogy 202 Ventilator Germany | In distribution | |
| Trilogy 202 Ventilator, China | In distribution | |
| Trilogy200 Ventilator, Germany | In distribution | |
| U1054260B | In distribution | |
| Trilogy Evo Ventilator, Iberia | In distribution | |
| 00 | In distribution | |
| Trilogy200 Ventilator, Japan | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 2,838 |
| APK | APK Technology Co., Ltd. | 2,678 |
| ChoiceMMed | Beijing Choice Electronic Technology Co., Ltd. | 151 |
| Nellcor | Covidien LP | 138 |
| Nonin | Nonin Medical, Inc. | 129 |
| Orantech | Orantech Inc. | 97 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 93 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Medichoice | Owens & Minor Distribution, Inc. | 62 |
| Caremed | Shenzhen Caremed Medical Technology Co., Ltd. | 55 |
| Sensoronics | Sensoronics Incorporated | 53 |
| Virtuox | Healthcare Logistics Systems | 36 |
Showing 12 of 1,063. All products under Oximeter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K972829 | 1997-10-28 |
Recalls Naming This Product
9 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 |
|---|---|---|---|---|---|---|---|
| Respironics Inc. | 510(k) number | 2022-12-07 | Class I | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which c | 20,807 | |
| Respironics Inc. | 510(k) number | 2022-12-07 | Class I | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which c | 537 devices | |
| Respironics Inc. | 510(k) number | 2022-12-07 | Class I | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which c | 9 | |
| Respironics Inc. | 510(k) number | 2021-06-14 | Class I | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | 255810 | |
| Philips Respironics, Inc. | 510(k) number | 2016-01-18 | Class II | Software design | Software Issue | 104,508 units | 2017-05-26 |
| Respironics Inc. | 510(k) number | 2014-02-11 | Class I | Component design/selection | Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients. | 572 | 2015-04-17 |
| Respironics Inc. | 510(k) number | 2012-04-27 | Class I | Component design/selection | The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply. | 173 | 2012-11-01 |
| Respironics Inc. | 510(k) number | 2011-10-11 | Not classified | Process design | Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the | 127 | 2012-11-06 |
| Respironics Inc. | 510(k) number | 2010-06-10 | Not classified | Nonconforming Material/Component | It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event. | 23 units | 2010-11-18 |
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.