Level 1
49 catalogue numbers from EQ-5000HF-INT-115V, listed by ICU Medical, Inc, United States, under System, Thermal Regulating. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
49catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Anhui (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Copious Intl., Inc. | Heyuan, Guangdong Province | Contract manufacturer | 11 | |
| Jiangyin Puremed | Jiangyin | Jiangsu | Contract manufacturer | 7 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Xodus Medical Company Limited | Shanghai | Shanghai | Specification developer | 25 |
| Hangzhou Tappa Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 3 |
| Jiangmen Dacheng Medical Equipment Co., Ltd. | Jiangmen | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K011907 |
| Record published | 2016-10-14 |
| Record revised | 2025-04-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 10, case of 10, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EQ-5000HF-INT-115V | In distribution | |
| SWU-2018 | In distribution | |
| SW-2013 | In distribution | |
| EQ-5000HF-ES-115V | In distribution | |
| SW-2016 | In distribution | |
| SW-2113 | In distribution | |
| SW-2019 | In distribution | |
| SW-2010 | In distribution | |
| SWU-2002 | In distribution | |
| L1-Cart | In distribution | |
| SW-2014R | In distribution | |
| F3-5000 | In distribution | |
| SWU-2011 | In distribution | |
| SWU-2003 | In distribution | |
| SWU-2014R | In distribution | |
| SW-2001 | In distribution | |
| L1-PWR-B-5 | In distribution | |
| SWU-2010 | In distribution | |
| SW-2018 | In distribution | |
| SWU-2009 | In distribution | |
| SWU-2014L | In distribution | |
| EQ-5000 115V | In distribution | |
| EQ-5000 | In distribution | |
| SW5-HOSE-7 | In distribution | |
| EQ-5000-INT-115V | In distribution | |
| EQ-5000-ES-115V | In distribution | |
| L1-PWR-B | In distribution | |
| SW-2003 | In distribution | |
| SWU-2113 | In distribution | |
| L1-FILTER | In distribution | |
| SW-2002 | In distribution | |
| SWU-2016 | In distribution | |
| SWU-2004 | In distribution | |
| SW-2011 | In distribution | |
| SWU-2001 | In distribution | |
| L1-Hose | In distribution | |
| SWU-2013 | In distribution | |
| SWU-2007 | In distribution | |
| L1-CLAMP | In distribution | |
| SW-2014L | In distribution | |
| L1-CW-120V | In distribution | |
| EQ-5000HF-EN-115V | In distribution | |
| SWU-2008 | In distribution | |
| SW-2004 | In distribution | |
| SW-2009 | In distribution | |
| SW-2008 | In distribution | |
| L1-Shelf | In distribution | |
| SWU-2119 | In distribution | |
| SW-2007 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mistral-Air | The Surgical Company International B.V. | 114 |
| Bair Hugger™ | 3M Company | 99 |
| IOB | Jiangmen Dacheng Medical Equipment Co., Ltd. | 68 |
| IOB | Iob Medical, Inc. | 61 |
| 3M™ Bair Hugger™ | 3M Company | 61 |
| Cocoon | Care Essentials PTY Ltd | 59 |
| Soft Air | Adroit Medical Systems, Inc. | 56 |
| System, Thermal Regulating | Hangzhou Tappa Medical Technology Co., Ltd. | 47 |
| PremierPro | Prestige Ameritech | 39 |
| Bair Paws™ | 3M Company | 30 |
| SourceMark | Sourcemark, LLC. | 25 |
| Kozee | Sourcemark, LLC. | 24 |
Showing 12 of 166. All products under System, Thermal Regulating
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2014-04-22 | Class II | Process change control | The hose could separate from the blanket. | 2120 devices | 2015-02-27 |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-12-15 | Not classified | Other | Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt | 206 units | 2006-06-27 |
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.