Extension Set
Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler blood and infusion warmer. Luer-Lock, bubble trap and injection port.
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
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 | Biegler Gmbh, Austria |
|---|---|
| FDA product code | LGZ |
| Device type | Warmer, Thermal, Infusion Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K121198 |
| Record published | 2024-06-04 |
| Record revised | 2024-06-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 100, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35000 | In distribution | |
| 25000 | In distribution | |
| 46000 | 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 |
|---|---|
| K121198 | 2012-07-12 |
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.