Tecotherm
TC-MATT-NEO Reusable Mattress for Tecotherm Neo
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Sichuan.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sichuan AST Medical Equipment Co., Ltd. | Luzhou | Sichuan | Contract manufacturer | 18 |
Record
| Listed by | Inspiration Medical Technology, Inc., United States |
|---|---|
| FDA product code | FOH |
| Device type | Mattress, Water, Temperature Regulated |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5560 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2016-11-07 |
| Record revised | 2023-12-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TC-MATT-DISP | In distribution | |
| TC-MATT-NEO | In distribution | |
| TC-MATT-NEO | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| STX Surface Cooling | Zoll Circulation, Inc. | 3 |
| TCmatt | TEC COM Medizintechnik Gmbh | 2 |
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.