ThermaCor 1200 Infusion System
Cassette with Patient Line and 3 Spike Set
5manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Smisson-Cartledge Biomedical LLC, United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K052055 |
| Record published | 2016-07-15 |
| Record revised | 2023-07-03 (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, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 10 to 100 % RH |
| Packaging | Case of 4, box of 6, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PTC-1200 | In distribution | |
| TSS-1200 | In distribution | |
| RCE-1200 | In distribution | |
| CG-1200 | In distribution | |
| TD-1200 | In distribution | |
| RCAU-1200 | In distribution | |
| PNC-1200 | In distribution | |
| TIS-1200 | In distribution | |
| RC-1200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
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.