Mark 5 Nuvo 8
230V Ocsi 8LPM Oxygen Concentrator -- Private Labeled FOR GCE Mediline, UK Plug
22manufacturers in China registered for this device type
12catalogue numbers in this listing
7510(k) clearances naming this product code
9recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (5), Beijing (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Kycare Medical Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 3 |
| Jakamed Instruments Co., Ltd. | Changsha | Hunan | Contract manufacturer | 2 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Jiangsu Yuyue Medical Equipment & Supply Company Limited | Jiangsu | Jiangsu | Contract manufacturer | 17 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Danyang Huayi Medical Supply & Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 11 |
| Shandong Moonlight Electronics Tech Co., Ltd. | Weifang | Shandong | Manufacturer | 11 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| Beijing Choicemmed Technology Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 9 |
| Foshan Care Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
| Zhengzhou Olive Electronic Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Generator, Oxygen, Portable
Record
| Listed by | Nidek Medical Products, Inc., United States |
|---|---|
| FDA product code | CAW |
| Device type | Generator, Oxygen, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5440 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K123738 |
| Record published | 2016-08-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 64 to 101 KiloPascal; Storage environment humidity 15 to 95 % RH; Storage environment temperature -20 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 985GCUK | In distribution | |
| 985NI | In distribution | |
| 985UK | In distribution | |
| 980 | In distribution | |
| 980UK | In distribution | |
| 580NSH | In distribution | |
| 985DP | In distribution | |
| 580 | In distribution | |
| 980DP | In distribution | |
| 585 | In distribution | |
| 985 | In distribution | |
| 985GC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeVilbiss | DeVilbiss Healthcare LLC. | 50 |
| EverFlo | Respironics Inc. | 32 |
| Mark 5 Nuvo Lite | Nidek Medical Products, Inc. | 30 |
| SimplyGo Mini | Respironics Inc. | 26 |
| X-PLO2R | Belluscura, LLC | 17 |
| ViveBreathe | Vive Health LLC | 11 |
| Invacare® HomeFill® Oxygen System | Invacare GmbH | 11 |
| Discov-R | Belluscura, LLC | 11 |
| NewLife Elite | Caire Inc. | 10 |
| NewLife Elite | Airsep Corp. | 10 |
| Rhythm Healthcare | Qingdao Kingon Medical Science AND Technology Co., Ltd. | 9 |
| OxyGo | Mv Life, LLC | 9 |
Showing 12 of 187. All products under Generator, Oxygen, Portable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192693 | 2020-05-07 |
| K123738 | 2013-02-28 |
| K093308 | 2010-01-14 |
| K082566 | 2008-12-03 |
| K040892 | 2004-04-29 |
| K032509 | 2004-03-18 |
| K883591 | 1988-11-02 |
Recalls
9 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-05-01 | Class I | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 7889 units | 2017-03-21 |
| 2012-05-01 | Class I | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 3638 units | 2017-03-21 |
| 2012-05-01 | Class I | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 14,585 units | 2017-03-21 |
| 2012-05-01 | Class I | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 1599 units | 2017-03-21 |
| 2012-05-01 | Class I | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 2017-03-21 | |
| 2012-05-01 | Class I | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 335 units | 2017-03-21 |
| 2012-05-01 | Class I | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 82 units | 2017-03-21 |
| 2012-05-01 | Class I | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 730 units | 2017-03-21 |
| 2012-05-01 | Class I | Component design/selection | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 18114 units | 2017-03-21 |
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.