HEPA Filter
*HEPA Filter with Port and Elbow (6224)
1manufacturer
2catalogue numbers in this listing
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 | Westmed, Inc., United States |
|---|---|
| FDA product code | MOD |
| Device type | Accessory To Continuous Ventilator (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K040712 |
| Record published | 2016-12-23 |
| Record revised | 2025-03-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 50 |
| Distribution end date | 2025-03-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6234 | 100 | In distribution | |
| F300A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 99 |
| Filter | Westmed, Inc. | 3 |
| 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 |
| Respironics Domed (Gherkin) | 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.