Soteria Bed Barrier
Soteria Bed Barrier is a fitted cover that protects compatible healthcare mattresses and bed decks from soiling and fluid penetration. It fits over the mattress and attaches to the bed…
Soteria Bed Barrier is a fitted cover that protects compatible healthcare mattresses and bed decks from soiling and fluid penetration. It fits over the mattress and attaches to the bed frame.
The barrier uses knitted polyester with a polyurethane coating. Hooks, clips, elastic and fitted head and foot pockets secure it in position while allowing sheets to fit over the mattress.
Listed Item
Includes x-ray port option
Fit and Reprocessing
Different configurations fit specified beds and mattresses, with color-coded labels and edge ribbons identifying compatible models. The barrier is nonsterile and reusable. It is removed when soiled or between patients, laundered using its validated procedure, then inspected, folded and wrapped 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 | 2023-03-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Universal 80x42x7 804207-800S | In distribution | |
| TotalCare Therapy TTCTHP-0110 | In distribution | |
| Affinity Therapy Foot V AFTHPV-000F | In distribution | |
| InTouch Standard INTSTD-5000 | In distribution | |
| CareAssist Standard CASSTD-0000 | In distribution | |
| Centrella Max CENMAX-0100 | In distribution | |
| Advanta Standard ADVSTD-000S | In distribution | |
| Progressa Therapy PRGTHP-0110 | In distribution | |
| Progressa Standard PGRSTD-0000 | In distribution | |
| Secure II/S3 Bed Extender S23EXT-0000 | In distribution | |
| GoBed PositionPro GBDPOS-0000 | In distribution | |
| Universal 80x42x9 804209-A00S | In distribution | |
| GoBed Standard GBDSTD-5000 | In distribution | |
| Centrella Pro+ CENPRO-0100 | In distribution | |
| LD304 Foot SLD304-000F | In distribution | |
| Universal 80x36x7 803607-800S | In distribution | |
| InTouch Isolibrium INTISO-0000 | In distribution | |
| CareAssist Therapy CASTHP-700S | In distribution | |
| MultiCare Standard MCRSTD-0000 | In distribution | |
| MultiCare Therapy MCRTHP-9000 | In distribution | |
| LD304 Head SLD304-000H | In distribution | |
| Compella Therapy COMTHP-1000 | In distribution | |
| InTouch IsoTour INTITR-4000 | In distribution | |
| CareAssist Therapy CASTHP-2000 | In distribution | |
| Centrella Standard CENSTD-0000 | In distribution | |
| InTouch IsoAir 2.0 INTAIR-4000 | In distribution | |
| Centrella Therapy CENTHP-0000 | In distribution | |
| Eleganza Therapy ELGTHP-2000 | In distribution | |
| VersaCare Standard VSCSTD-0000 (w/Button) | In distribution | |
| Eleganza Standard ELGSTD-0000 | In distribution | |
| Affinity Therapy Head U AFTHPU-000H | In distribution | |
| CareAssist Standard CASSTD-000S | In distribution | |
| Affinity Therapy Foot U AFTHPU-000F | In distribution | |
| Universal 80x36x9 803609-A00S | In distribution | |
| Affinity Therapy Head V AFTHPV-000H | In distribution | |
| Secure II/S3 Standard S23STD-5000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soteria Mattress Barrier | Trinity Guardion, Inc. | 8 |
| 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.