Smithworks Medical, Inc.
The Thermal Sack Pressure Infuser, also known as TSPI, is designed to be used with any of our iv fluid warmers as a thermal maintenance tool. The TSPI employs chemical hot packs to maintain…
The Thermal Sack Pressure Infuser, also known as TSPI, is designed to be used with any of our iv fluid warmers as a thermal maintenance tool. The TSPI employs chemical hot packs to maintain target temperatures for up to an hour after deployment. There are no electronics within this device.
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 BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Smithworks, Inc., United States |
|---|---|
| FDA product code | LGZ |
| Device type | Warmer, Thermal, Infusion Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Remanufacturer, Manufacturer |
| Record published | 2024-04-08 |
| Record revised | 2026-05-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12VPK3L12 | In distribution | |
| 12VFM4L02 | In distribution | |
| TSPI05 | In distribution | |
| 12VPK2L02-C | In distribution | |
| 12VSS3L02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pedigo Products, Inc. | Pedigo Products, Inc. | 207 |
| Amsco | Steris Corporation | 38 |
| Level 1 | ICU Medical, Inc | 26 |
| Skytron warming cabinet | Skytron, LLC | 24 |
| ThermaCor 1200 Infusion System | Smisson-Cartledge Biomedical LLC | 11 |
| Astoflo® Plus ECO | Stihler Electronic Gmbh | 10 |
| enFlow | Carefusion | 8 |
| Fluido® AirGuard System | The Surgical Company International B.V. | 7 |
| Warming Cabinet Single Compartment Counter-Top Model (Glass Door) | Imperial Surgical Ltd. | 4 |
| Hang&Go PAC | Rand SPA | 4 |
| enFlow™ | Airlife, Inc. | 4 |
| Enteral Feeding | Medela LLC | 4 |
Showing 12 of 159. All products under Warmer, Thermal, Infusion Fluid
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.