Medline-Microtek
Solution Warmer, 230V for use with the Hush-Slush™ Model ORS-1075EU
1manufacturer
23catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
Record
| Listed by | Microtek Medical LLC, United States |
|---|---|
| FDA product code | LHC |
| Device type | Warmer, Irrigation Solution |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5950 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-18 |
| Record revised | 2025-10-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment temperature 10 to 100 % RH |
| Packaging | Case of 24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Fluid Warming – Warmer Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Fluid Warming – Ecolab Warmer Equipment | In distribution | |
| Fluid Warming – CoreTemp Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Surgical Slush – Hush Slush Equipment | In distribution | |
| Surgical Slush – Hush-Slush Equipment | In distribution | |
| Surgical Slush – Hush Slush Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Fluid Warming – IntraTemp Equipment | In distribution | |
| Surgical Slush – Hush-Slush Equipment | In distribution | |
| Surgical Slush – Hush-Slush Equipment | In distribution | |
| Surgical Slush – Hush-Slush Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution | |
| Surgical Slush – Hush-Slush Equipment | In distribution | |
| Fluid Warming – CoreTemp Equipment | In distribution | |
| Fluid Warming – Warmer Equipment | In distribution |
Same Product Code
Showing 12 of 123. All products under Warmer, Irrigation Solution
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.