Barkey S-Line
The Barkey S-line warms blood, blood products and other liquids during intravenous administration to adults and children. It is used in hospitals and clinical settings where warmed IV…
The Barkey S-line warms blood, blood products and other liquids during intravenous administration to adults and children. It is used in hospitals and clinical settings where warmed IV fluids are required. Fluid travels through a compatible IV extension set placed in a groove within the warming sleeve.
Heating wires embedded in the sleeve transfer heat through the IV tubing. The warmer does not directly contact the fluid. Its temperature setting is fixed at 39°C, and temperature is monitored where the extension set leaves the sleeve. The setting cannot be adjusted by the user.
Listed Item
The device delivers warm blood, blood products, and liquids to adult and pediatric patients
Overtemperature Protection
An independent protector monitors the warming section. A second safety feature turns off its heater at 43°C, with a tolerance of 1°C, and activates a yellow visual indicator and an audible alarm.
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 | Barkey GmbH & Co. KG, Germany |
|---|---|
| FDA product code | LGZ |
| Device type | Warmer, Thermal, Infusion Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| 510(k) | K213191 |
| Record published | 2022-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 30 to 90 % RH; Storage environment temperature -20 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 39 °C | 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 |
| 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 |
|---|---|
| K213191 | 2022-05-24 |
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.