Soteria Mattress Barrier
The Soteria Mattress Barrier covers compatible healthcare mattresses and bed decks to form a physical barrier between the equipment and the patient. It prevents fluids and soiling from…
The Soteria Mattress Barrier covers compatible healthcare mattresses and bed decks to form a physical barrier between the equipment and the patient. It prevents fluids and soiling from reaching the underlying surfaces, helping to reduce contamination during use.
The cover fits over the mattress and attaches to the bed frame with hooks or clips. Pockets at the head and foot secure the mattress, allowing fitted sheets to be placed over it. Labels and coloured edging identify the compatible bed and mattress configuration.
Reuse
The barrier is supplied non-sterile and is reusable. It is removed when soiled and between patients, then laundered according to its validated procedure, inspected and prepared for reuse.
Who Else Makes It
Concentrated in Hebei (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hebei Junlaole Medical Technology Co., Ltd. | Hengshui | Hebei | Manufacturer | 15 |
| QuantMed LifeTech (Shenzhen) Co., Ltd. | Shenzhencity | Guangdong | Manufacturer | 6 |
Record
| Listed by | Trinity Guardion, Inc., United States |
|---|---|
| FDA product code | QTV |
| Device type | Mattress And Bed Deck Cover (Medical Purposes) |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6190 |
| Establishment | Manufacturer |
| 510(k) | K201876 |
| Record published | 2025-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Universal 84x35x8 843508-0E00 | In distribution | |
| Universal Stretcher STRU26-0000 | In distribution | |
| Universal 84x35x8 843508-0M00 | In distribution | |
| Universal 80x48x9 804809-A00S | In distribution | |
| Gynnie Stretcher Head STRGYN-000H | In distribution | |
| Universal Stretcher STRU30-0000 | In distribution | |
| Gynnie Stretcher Foot STRGYN-000F | In distribution | |
| Universal 75x38x6 753806-000S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soteria Bed Barrier | Trinity Guardion, Inc. | 36 |
| Meridian | Drive DeVilbiss Healthcare | 6 |
| Starsleep | Shanghai Charme Health Technology Co., Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201876 | 2022-09-01 |
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.