BioFlo
15.5Fx32cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
2manufacturers in China registered for this device type
45catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Record published | 2015-09-17 |
| Record revised | 2021-05-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
| Sizes | Length 20 to 55 cm; outer diameter 5.2 mm; catheter gauge 15.5 Fr; needle gauge 18 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03-820 | Length 32 cm | In distribution |
| 03-804 | Outer Diameter 5.2 mm | In distribution |
| 03-801 | Needle Gauge 18 G | In distribution |
| 03-805 | Needle Gauge 18 G | In distribution |
| 02-804 | Needle Gauge 18 G | In distribution |
| 02-817 | Outer Diameter 5.2 mm | In distribution |
| 02-820 | Length 32 cm | In distribution |
| 03-807 | Catheter Gauge 15.5 Fr | In distribution |
| 03-817 | Length 22 cm | In distribution |
| 02-905 | Catheter Gauge 15.5 Fr | In distribution |
| 02-803 | Outer Diameter 5.2 mm | In distribution |
| 02-824 | Length 55 cm | In distribution |
| 02-807 | Length 40 cm | In distribution |
| 03-822 | Outer Diameter 5.2 mm | In distribution |
| 03-818 | Length 24 cm | In distribution |
| 02-809 | Catheter Gauge 15.5 Fr | In distribution |
| 02-808 | Length 48 cm | In distribution |
| 03-808 | Outer Diameter 5.2 mm | In distribution |
| 02-818 | Catheter Gauge 15.5 Fr | In distribution |
| 03-806 | Needle Gauge 18 G | In distribution |
| 02-805 | Catheter Gauge 15.5 Fr | In distribution |
| 02-822 | Length 40 cm | In distribution |
| 03-802 | Needle Gauge 18 G | In distribution |
| 03-819 | Outer Diameter 5.2 mm | In distribution |
| 03-821 | Length 36 cm | In distribution |
| 02-823 | Outer Diameter 5.2 mm | In distribution |
| 02-806 | Needle Gauge 18 G | In distribution |
| 03-824 | Catheter Gauge 15.5 Fr | In distribution |
| 03-816 | Length 20 cm | In distribution |
| 02-821 | Catheter Gauge 15.5 Fr | In distribution |
| 02-902 | Outer Diameter 5.2 mm | In distribution |
| 02-906 | Catheter Gauge 15.5 Fr | In distribution |
| 02-802 | Length 22 cm | In distribution |
| 02-904 | Length 28 cm | In distribution |
| 02-901 | Catheter Gauge 15.5 Fr | In distribution |
| 03-809 | Needle Gauge 18 G | In distribution |
| 03-803 | Outer Diameter 5.2 mm | In distribution |
| 02-819 | Outer Diameter 5.2 mm | In distribution |
| 02-801 | Needle Gauge 18 G | In distribution |
| 02-816 | Catheter Gauge 15.5 Fr | In distribution |
| 02-903 | Outer Diameter 5.2 mm | In distribution |
| 02-908 | Catheter Gauge 15.5 Fr | In distribution |
| 02-909 | Length 55 cm | In distribution |
| 03-823 | Outer Diameter 5.2 mm | In distribution |
| 02-907 | Length 40 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 406 |
| Split Cath® III | Medical Components Inc | 277 |
| Palindrome | Mozarc Medical US LLC | 139 |
| Titan HD | Medical Components Inc | 75 |
| ProGuide™ | Merit Medical Systems, Inc. | 72 |
| Hemo-Flow® | Medical Components Inc | 65 |
| DuraMax® | Merit Medical Systems, Inc. | 55 |
| CentrosFLO® | Merit Medical Systems, Inc. | 51 |
| BioFlo DuraMax® | Merit Medical Systems, Inc. | 51 |
| DuraFlow | AngioDynamics, Inc. | 37 |
| Mahurkar | Mozarc Medical US LLC | 37 |
| HemoSplit Long-Term Hemodialysis Catheter | Bard Access Systems, Inc. | 35 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131260 | 2014-02-14 |
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.