ThermaCor 1200 Infusion System
UK Detachable Power Cord Set
1manufacturer
11catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls on this code
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 | Smisson-Cartledge Biomedical LLC, United States |
|---|---|
| FDA product code | LGZ |
| Device type | Warmer, Thermal, Infusion Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K052055 |
| Record published | 2016-07-15 |
| Record revised | 2023-07-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 10 to 100 % RH |
| Packaging | Case of 4, box of 15, box of 12, box of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EL-1200 | In distribution | |
| PL-1200 | In distribution | |
| DL-1200 | In distribution | |
| TH-1200 | In distribution | |
| FS-1200 | In distribution | |
| RCB-1200 | In distribution | |
| MH-1200 | In distribution | |
| SP-1200 | In distribution | |
| DC-1200 | In distribution | |
| MR-1200 | In distribution | |
| DNC-1200 | 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 |
| Astoflo® Plus ECO | Stihler Electronic Gmbh | 10 |
| enFlow | Carefusion | 8 |
| Fluido® AirGuard System | The Surgical Company International B.V. | 7 |
| Smithworks Medical, Inc. | Smithworks, Inc. | 5 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202461 | 2022-08-12 |
| K052055 | 2006-10-26 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smisson-Cartledge Biomedical LLC | 510(k) number | 2021-02-18 | Class I | Component design/selection | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. | 18482 devices | 2024-04-26 |
| Smisson-Cartledge Biomedical LLC | 510(k) number | 2021-02-18 | Class I | Component design/selection | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. | 7118 devices | 2024-04-26 |
| Smisson-Cartledge Biomedical LLC | 510(k) number | 2021-02-18 | Class I | Component design/selection | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. | 11768 devices | 2024-04-26 |
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.