Meridian
SGU 48" Universal SAFE-T-GUARD
2manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | Drive DeVilbiss Healthcare, 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 | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2020-02-28 |
| Record revised | 2026-05-27 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SGU48_FG | In distribution | |
| SGU_84 | In distribution | |
| SGU42_FG | In distribution | |
| SG8_FG | In distribution | |
| SG5_FG | In distribution | |
| SGU_FG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soteria Bed Barrier | Trinity Guardion, Inc. | 36 |
| Soteria Mattress Barrier | Trinity Guardion, Inc. | 8 |
| Starsleep | Shanghai Charme Health Technology Co., Ltd. | 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.