Amsco
The AMSCO Warming Cabinet OR Consolidated with 120V, 24-inch wide, with Premium Dual Compartment, glass door, 18-inch depth, Electronic Door Locks and Electronic Data Recording is designed…
The AMSCO Warming Cabinet OR Consolidated with 120V, 24-inch wide, with Premium Dual Compartment, glass door, 18-inch depth, Electronic Door Locks and Electronic Data Recording is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
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 | Steris Corporation, United States |
|---|---|
| FDA product code | LGZ |
| Device type | Warmer, Thermal, Infusion Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K092823 |
| Record published | 2026-02-13 |
| Record revised | 2020-11-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Warming Cabinet | In distribution | |
| DJ03012413112 | In distribution | |
| DJ06012412312 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ06012433111 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ06012412313 | In distribution | |
| DJ06012433112 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ050124332 | In distribution | |
| DJ050124132 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ060124331 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ02012433212 | In distribution | |
| DJ05012433212 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ020124332 | In distribution | |
| CB1721002001 | In distribution | |
| DJ030124131 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ04012433113 | In distribution | |
| DJ01012413212 | In distribution | |
| DJ060124131 | In distribution | |
| Warming Cabinet | In distribution | |
| CB4721003001 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ010124132 | In distribution | |
| DJ040124331 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ04012433111 | In distribution | |
| Warming Cabinet | In distribution | |
| DJ06012413112 | In distribution | |
| DJ06012433113 | In distribution | |
| CB172100200101 | In distribution | |
| DJ05012413212 | In distribution | |
| DJ04012433112 | In distribution | |
| CB472100200101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pedigo Products, Inc. | Pedigo Products, Inc. | 207 |
| 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 |
| Enteral Feeding | Medela LLC | 4 |
Showing 12 of 159. All products under Warmer, Thermal, Infusion Fluid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111870 | 2011-07-29 |
| K110769 | 2011-06-03 |
| K092823 | 2009-12-18 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-11-20 | Class II | Process change control | The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature. | 2,319 units | 2016-10-27 |
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.