V8800 Critical Care Ventilator
Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. French Canada Language. USA Power Setup
23manufacturers in China registered for this device type
10catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Nantong Kangjinchen Medical Equipment Co., Ltd. | Nantong | Jiangsu | Manufacturer | 17 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Showing 12 of 23. All 23 manufacturers in China registered for Compressor, Air, Portable
Record
| Listed by | Oricare Inc., United States |
|---|---|
| FDA product code | BTI |
| Device type | Compressor, Air, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.6250 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K120931 |
| Record published | 2016-03-25 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 5 to 95 % RH; Storage environment temperature -20 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V8800 | In distribution | |
| V8800 | In distribution | |
| V8800 | In distribution | |
| V8800 | In distribution | |
| V8800 | In distribution | |
| V8800 | In distribution | |
| V8800 | In distribution | |
| V8800 | In distribution | |
| V8800 | In distribution | |
| V8800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InnoSpire Elegance | Respironics Respiratory Drug Delivery (Uk), Ltd. | 124 |
| InnoSpire Essence | Respironics Respiratory Drug Delivery (Uk), Ltd. | 37 |
| Medline | Medline Industries, Inc. | 28 |
| Roscoe Medical | Drive DeVilbiss Healthcare | 19 |
| Drive | Drive DeVilbiss Healthcare | 18 |
| Timeter | Allied Medical LLC | 16 |
| DK50 DS | Ekom Spol. S R.O. | 11 |
| Medquip | Drive DeVilbiss Healthcare | 9 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 6 |
| MedPak | Lifeport, LLC. | 5 |
| Carex Health Brands | Drive DeVilbiss Healthcare | 5 |
| C235 | Ekom Spol. S R.O. | 5 |
Showing 12 of 101. All products under Compressor, Air, Portable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113338 | 2012-08-10 |
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.