Respironics Domed (Gherkin)
Catalogue number 3400/01AIUA058/0001, listed by GVS Filter Technology UK Ltd, United Kingdom, under Accessory To Continuous Ventilator (Respirator). 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
Record
| Listed by | GVS Filter Technology UK Ltd, United Kingdom |
|---|---|
| FDA product code | MOD |
| Device type | Accessory To Continuous Ventilator (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K040712 |
| Record published | 2016-09-23 |
| Record revised | 2026-02-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -5 to 40 °C |
| Packaging | Box of 150 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3400/01AIUA058/0001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 99 |
| Filter | Westmed, Inc. | 3 |
| HEPA Filter | Westmed, Inc. | 2 |
| CorVent® CorVision | Corvent Medical Inc. | 1 |
| Tyco-Achieva Bulk | GVS Filter Technology UK Ltd | 1 |
| CorVision with Display | Corvent Medical Inc. | 1 |
| Inogen | GVS Filter Technology UK Ltd | 1 |
| Procure | Twin Med, LLC | 1 |
| Cart, Display Enclosure 11 inch | Corvent Medical Inc. | 1 |
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.