BioFlo
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit.
5manufacturers in China registered for this device type
658catalogue numbers in this listing
16510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Record published | 2015-09-18 |
| Record revised | 2024-03-25 (version 7) |
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 |
| Storage | Storage environment temperature 15 to 29 °C |
| Packaging | Box of 4, box of 3, box of 5 |
| Sizes | Catheter gauge 3 to 6 Fr; length 20 to 55 cm; outer diameter 1.02 to 2.2 mm; needle gauge 21 G; pressure 153 to 325 psi |
| Distribution end date | 2019-07-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60M700162 | Catheter Gauge 5 Fr | In distribution |
| PKM1815711S | Length 55 cm | In distribution |
| 60M060104 | Dual Lumen | In distribution |
| 75033 | Outer Diameter 1.73 mm | In distribution |
| 60M780183 | Length 55 cm | In distribution |
| 60M61128734 | Catheter Gauge 6 Fr | In distribution |
| PKM61020101S | Dual | In distribution |
| 60M163502 | Single Lumen | In distribution |
| 45885 | Catheter Gauge 4 Fr | In distribution |
| 45871 | Length 55 cm | In distribution |
| PKM61063011S | Dual | In distribution |
| PKM194923S | Length 55 cm | In distribution |
| 60M137542 | Dual | In distribution |
| 60M61102513 | Catheter Gauge 5 Fr | In distribution |
| PKM1815715S | Dual | In distribution |
| 45831 | Outer Diameter 1.75 mm | In distribution |
| 60M61105282 | Catheter Gauge 4 Fr | In distribution |
| 60M61105606 | Catheter Gauge 5 Fr | In distribution |
| 60M700011 | Catheter Gauge 4 Fr | In distribution |
| 60M140114 | Single Lumen | In distribution |
| PKM020915S | Length 55 cm | In distribution |
| PKMR215704S | Catheter Gauge 5 Fr | In distribution |
| 60M61011591 | Length 55 cm | In distribution |
| 60M701103 | Length 55 cm | In distribution |
| PKM1949617S | Catheter Gauge 5 Fr | In distribution |
| 75017 | Catheter Gauge 4 Fr | In distribution |
| PKM223925S | Catheter Gauge 5 Fr | In distribution |
| 60M131651 | Single | In distribution |
| 60M032721 | Single | In distribution |
| PKM1318424S | Length 55 cm | In distribution |
| PKM1220214S | Catheter Gauge 5 Fr | In distribution |
| 45838 | Needle Gauge 21 G | In distribution |
| 45842 | Outer Diameter 2.2 mm | In distribution |
| PKM61014921S | Single | In distribution |
| 60M138981 | Catheter Gauge 5 Fr | In distribution |
| PKM122365S | Dual | In distribution |
| PKM201907S | Dual | In distribution |
| 45869 | Catheter Gauge 6 Fr | In distribution |
| 60M122027 | Dual Lumen | In distribution |
| 75015 | Needle Gauge 21 G | In distribution |
| 60M183482 | Single Lumen | In distribution |
| 60M0501910 | Catheter Gauge 6 Fr | In distribution |
| 60M022474 | Dual Lumen | In distribution |
| 75-065 | Needle Gauge 21 G | In distribution |
| PKM032574S | Triple | In distribution |
| PKM020601S | Dual | In distribution |
| PKM034647S | Catheter Gauge 6 Fr | In distribution |
| 60M122025 | Catheter Gauge 4 Fr | In distribution |
| 45835 | Catheter Gauge 5 Fr | In distribution |
| PKM220923S | Length 55 cm | In distribution |
| 60M183481 | Dual Lumen | In distribution |
| 60M132584 | Catheter Gauge 5 Fr | In distribution |
| PKM1815714S | Length 55 cm | In distribution |
| PKM1815713S | Length 55 cm | In distribution |
| 45812 | Catheter Gauge 4 Fr | In distribution |
| 60M780122 | Length 55 cm | In distribution |
| PKM61014401S | Length 55 cm | In distribution |
| PKM020914S | Catheter Gauge 6 Fr | In distribution |
| 60M010434 | Length 55 cm | In distribution |
| 45888 | Length 55 cm | In distribution |
| 45879 | Length 55 cm | In distribution |
| PKM1220218S | Catheter Gauge 6 Fr | In distribution |
| 60M190311 | Catheter Gauge 4 Fr | In distribution |
| PKM1405610S | Catheter Gauge 5 Fr | In distribution |
| 60M195056 | Catheter Gauge 5 Fr | In distribution |
| 60M142593 | Length 55 cm | In distribution |
| 45805 | Needle Gauge 21 G | In distribution |
| PKM1938815S | Triple | In distribution |
| 60M1854511 | Catheter Gauge 4 Fr | In distribution |
| PKM1614910S | Length 55 cm | In distribution |
| 60M013353 | Length 55 cm | In distribution |
| PKM1938819S | Length 55 cm | In distribution |
| 60M132324 | Catheter Gauge 5 Fr | In distribution |
| 60M101822 | Length 55 cm | In distribution |
| 60M183483 | Single Lumen | In distribution |
| PKM3092663S | Length 55 cm | In distribution |
| PKM1803410S | Catheter Gauge 6 Fr | In distribution |
| 45896 | Needle Gauge 21 G | In distribution |
| 60M163421 | Length 55 cm | In distribution |
| 75-059 | Length 55 cm | In distribution |
| 45965 | Outer Diameter 2.11 mm | In distribution |
| 75-054 | Length 55 cm | In distribution |
| 45804 | Length 55 cm | In distribution |
| 60M041155 | Catheter Gauge 5 Fr | In distribution |
| H96560M1938851 | Catheter Gauge 4 Fr | In distribution |
| 60M194071 | Catheter Gauge 4 Fr | In distribution |
| PKM210503S | Length 55 cm | In distribution |
| 60M1220213 | Catheter Gauge 6 Fr | In distribution |
| PKM61057421S | Catheter Gauge 5 Fr | In distribution |
| 60M231608 | Dual | In distribution |
| PKM150125S | Catheter Gauge 5 Fr | In distribution |
| 60M61124581 | Length 55 cm | In distribution |
| 60M1224310 | Length 55 cm | In distribution |
| 60M122942 | Catheter Gauge 5 Fr | In distribution |
| 45889 | Outer Diameter 1.75 mm | In distribution |
| 60M138982 | Length 55 cm | In distribution |
| 60M163422 | Single Lumen | In distribution |
| 60M163503 | Length 55 cm | In distribution |
| pkm1803412s | Single | In distribution |
| 60M701101 | Catheter Gauge 4 Fr | In distribution |
| 60M013421 | Catheter Gauge 5 Fr | In distribution |
| 45943 | Length 55 cm | In distribution |
| PKM131934S | Length 55 cm | In distribution |
| 60M070163 | Catheter Gauge 5 Fr | In distribution |
| 60M140607 | Catheter Gauge 5 Fr | In distribution |
| 60M61105253 | Catheter Gauge 5 Fr | In distribution |
| PKM033511S | Dual | In distribution |
| 60M132323 | Single Lumen | In distribution |
| 60M1318411 | Triple | In distribution |
| PKM61102512S | Catheter Gauge 4 Fr | In distribution |
| PKM3070941S | Catheter Gauge 5 Fr | In distribution |
| PKM160312S | Length 55 cm | In distribution |
| 45875 | Length 55 cm | In distribution |
| 60M130312 | Catheter Gauge 3 Fr | In distribution |
| 45959 | Needle Gauge 21 G | In distribution |
| PKM1935812S | Length 55 cm | In distribution |
| PKM1401430S | Length 55 cm | In distribution |
| PKM61102513S | Catheter Gauge 5 Fr | In distribution |
| 60M780128 | Dual Lumen | In distribution |
| 60M101823 | Length 55 cm | In distribution |
| 75018 | Catheter Gauge 5 Fr | In distribution |
| PKM1815710S | Length 55 cm | In distribution |
| 75-045 | Catheter Gauge 5 Fr | In distribution |
| PKM100273S | Length 55 cm | In distribution |
| 45967 | Catheter Gauge 6 Fr | In distribution |
| 75-063 | Needle Gauge 21 G | In distribution |
| 60M61066148 | Triple | In distribution |
| PKM223598S | Catheter Gauge 5 Fr | In distribution |
| PKM61008021S | Length 55 cm | In distribution |
| 60M032722 | Dual | In distribution |
| 60M131849 | Catheter Gauge 4 Fr | In distribution |
| 46-026 | Needle Gauge 21 G | In distribution |
| 60M140861 | Length 55 cm | In distribution |
| 45884 | Needle Gauge 21 G | In distribution |
| 45893 | Catheter Gauge 6 Fr | In distribution |
| 60M3128611 | Length 55 cm | In distribution |
| PKM196042S | Length 55 cm | In distribution |
| 46-028 | Length 20 cm | In distribution |
| PKM61105252S | Length 55 cm | In distribution |
| 60M2103711 | Single | In distribution |
| PKM1837113S | Length 55 cm | In distribution |
| PKM016968S | Catheter Gauge 4 Fr | In distribution |
| 75-060 | Length 55 cm | In distribution |
| 60M61120023 | Length 55 cm | In distribution |
| 60M220443 | Length 55 cm | In distribution |
| PKM2301017S | Length 55 cm | In distribution |
| PKM1410019S | Length 55 cm | In distribution |
| 75-049 | Needle Gauge 21 G | In distribution |
| PKM150633S | Length 55 cm | In distribution |
| 60M250123 | Length 55 cm | In distribution |
| PKM2301018S | Catheter Gauge 5 Fr | In distribution |
| PKM1841110S | Length 55 cm | In distribution |
| PKM120654S | Catheter Gauge 4 Fr | In distribution |
| 60M131847 | Length 55 cm | In distribution |
| 60M131848 | Length 55 cm | In distribution |
| 60M185981 | Triple Lumen | In distribution |
| 60M701242 | Catheter Gauge 6 Fr | In distribution |
| PKM1841111S | Length 55 cm | In distribution |
| 75-058 | Outer Diameter 1.73 mm | In distribution |
| PKM120451S | Dual | In distribution |
| PKM1220223S | Catheter Gauge 5 Fr | In distribution |
| 75-066 | Outer Diameter 2.11 mm | In distribution |
| 60M1815711 | Length 55 cm | In distribution |
| PKM1303121S | Catheter Gauge 4 Fr | In distribution |
| 60M122436 | Length 55 cm | In distribution |
| PKM223595S | Length 55 cm | In distribution |
| 75014 | Pressure 325 psi | In distribution |
| PKM223594S | Length 55 cm | In distribution |
| PKM131111S | Length 55 cm | In distribution |
| 60M61066144 | Length 55 cm | In distribution |
| 60M780181 | Length 55 cm | In distribution |
| PKM100277S | Length 55 cm | In distribution |
| PKM010536S | Length 55 cm | In distribution |
| 60M3067602 | Length 55 cm | In distribution |
| PKM137541S | Catheter Gauge 5 Fr | In distribution |
| 60M122438 | Dual | In distribution |
| 60M250096 | Catheter Gauge 4 Fr | In distribution |
| 75021 | Needle Gauge 21 G | In distribution |
| PKM010535S | Catheter Gauge 6 Fr | In distribution |
| 45962 | Length 55 cm | In distribution |
| PKM020913S | Triple | In distribution |
| PKM132329S | Length 55 cm | In distribution |
| pkm1803413s | Dual | In distribution |
| PKM140343S | Catheter Gauge 3 Fr | In distribution |
| PKM034648S | Dual | In distribution |
| 60M180344 | Length 55 cm | In distribution |
| 60M140142 | Length 55 cm | In distribution |
| 45954 | Length 55 cm | In distribution |
| PKM0501917S | Catheter Gauge 5 Fr | In distribution |
| PKM1841112S | Dual | In distribution |
| 60M61094344 | Single | In distribution |
| 60M060103 | Catheter Gauge 4 Fr | In distribution |
| 60M184117 | Dual | In distribution |
| 45832 | Needle Gauge 21 G | In distribution |
| 60M184154 | Length 55 cm | In distribution |
| 60M034292 | Single Lumen | In distribution |
| PKM61008025S | Catheter Gauge 4 Fr | In distribution |
| 45897 | Needle Gauge 21 G | In distribution |
| PKM1815717S | Length 55 cm | In distribution |
| PKM033513S | Single | In distribution |
| PKM032251S | Single | In distribution |
| PKMR4024873S | Dual | In distribution |
| PKM250099S | Dual | In distribution |
| 60m180345 | Dual | In distribution |
| 60M163393 | Length 55 cm | In distribution |
| PKM032573S | Catheter Gauge 4 Fr | In distribution |
| 60M61066147 | Catheter Gauge 5 Fr | In distribution |
| PKM223001S | Catheter Gauge 5 Fr | In distribution |
| PKM1949615S | Catheter Gauge 5 Fr | In distribution |
| 60M130313 | Length 55 cm | In distribution |
| 60M700938 | Length 55 cm | In distribution |
| 75031 | Pressure 325 psi | In distribution |
| 60M140564 | Catheter Gauge 5 Fr | In distribution |
| 60M141006 | Catheter Gauge 5 Fr | In distribution |
| PKM137544S | Catheter Gauge 4 Fr | In distribution |
| 75-051 | Length 55 cm | In distribution |
| PKM1614915S | Single | In distribution |
| 60M010565 | Length 55 cm | In distribution |
| 45956 | Catheter Gauge 3 Fr | In distribution |
| 60M194073 | Catheter Gauge 6 Fr | In distribution |
| 60M61113982 | Single | In distribution |
| PKM131945S | DUAL | In distribution |
| 60M701104 | Length 55 cm | In distribution |
| 60M2316010 | Catheter Gauge 5 Fr | In distribution |
| 60M071831 | Length 55 cm | In distribution |
| 60M150373 | Length 55 cm | In distribution |
| 60M034642 | Length 55 cm | In distribution |
| 60M163501 | Length 55 cm | In distribution |
| 45958 | Catheter Gauge 3 Fr | In distribution |
| 45895 | Outer Diameter 1.75 mm | In distribution |
| PKM100235S | Dual | In distribution |
| 60M161568 | Length 55 cm | In distribution |
| 60M181577 | Single Lumen | In distribution |
| 75036 | Needle Gauge 21 G | In distribution |
| PKM61055311S | Length 55 cm | In distribution |
| PKM013421S | Length 55 cm | In distribution |
| PKM1303115S | Catheter Gauge 3 Fr | In distribution |
| PKM1220227S | Catheter Gauge 4 Fr | In distribution |
| 60M122026 | Single Lumen | In distribution |
| PKM1401425S | Single | In distribution |
| 60M180261 | Catheter Gauge 5 Fr | In distribution |
| PKM210501S | Length 55 cm | In distribution |
| 60M61135443 | Length 55 cm | In distribution |
| 75-044 | Length 55 cm | In distribution |
| 60M137543 | Single | In distribution |
| 75012 | Pressure 325 psi | In distribution |
| PKM196043S | Catheter Gauge 6 Fr | In distribution |
| 60M100725 | Length 55 cm | In distribution |
| PKMR215702S | Catheter Gauge 4 Fr | In distribution |
| PKM210171S | Length 55 cm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
| Vygon | Vygon Corp. | 50 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163452 | 2017-02-03 |
| K152409 | 2015-09-24 |
| K150527 | 2015-03-31 |
| K150448 | 2015-03-19 |
| K142616 | 2014-10-14 |
| K140266 | 2014-03-05 |
| K133264 | 2013-11-20 |
| K131942 | 2013-07-31 |
| K131038 | 2013-05-09 |
| K122882 | 2012-10-18 |
| K121089 | 2012-08-23 |
| K121990 | 2012-08-03 |
| K111906 | 2011-07-29 |
| K101326 | 2010-09-02 |
| K093366 | 2009-11-24 |
| K091261 | 2009-05-12 |
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.