Chinese, Rapid Infuser, 230 V, 750ml/min
Catalogue number 903-00001A-C, listed by Belmont Instrument Corp., United States, under Warmer, Thermal, Infusion Fluid. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
6510(k) clearances naming this product 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 | Belmont Instrument Corp., United States |
|---|---|
| FDA product code | LGZ |
| Device type | Warmer, Thermal, Infusion Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| 510(k) | K091855 |
| Record published | 2016-09-24 |
| Record revised | 2024-02-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 903-00001A-C | Withdrawn |
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 |
| 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 |
Showing 12 of 159. All products under Warmer, Thermal, Infusion Fluid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152208 | 2015-09-02 |
| K131519 | 2013-11-06 |
| K090089 | 2009-02-12 |
| K070654 | 2007-06-08 |
| K032778 | 2003-09-22 |
| K032674 | 2003-09-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Belmont Medical Technologies | 510(k) number | 2012-09-25 | Class II | Device Design | Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area. | 2,913 units | 2014-02-28 |
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.