Xcela
Xcela Hybrid PICC with PASV Valve Technology - 6Fx55cm Triple Lumen Catheter Intermediate MST-45 Kit with Lidocaine
5manufacturers in China registered for this device type
271catalogue 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 | 2015-09-17 |
| Record revised | 2024-03-25 (version 5) |
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 20 to 25 °C |
| Packaging | Box of 4, box of 5, box of 3 |
| Sizes | Length 45 to 55 cm; catheter gauge 3 to 6 Fr; outer diameter 1.05 to 2.2 mm; needle gauge 21 G; pressure 233 to 325 psi |
| Distribution end date | 2019-03-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60M121681 | Single Lumen | In distribution |
| 60M210375 | Single Lumen | In distribution |
| 60M161363 | Catheter Gauge 5 Fr | In distribution |
| 45667 | Needle Gauge 21 G | In distribution |
| 60M023904 | Catheter Gauge 5 Fr | In distribution |
| 60M194922 | Catheter Gauge 5 Fr | In distribution |
| 60M010185 | Length 55 cm | In distribution |
| 45671 | Catheter Gauge 5 Fr | In distribution |
| 95245 | Outer Diameter 2.2 mm | In distribution |
| 60M011612 | Catheter Gauge 4 Fr | In distribution |
| PKMR61010899S | Catheter Gauge 5 Fr | In distribution |
| 60M232594 | Length 55 cm | In distribution |
| PKM1636014S | Length 55 cm | In distribution |
| 45701 | Length 55 cm | In distribution |
| 45664 | Pressure 300 psi | In distribution |
| 60M230103 | Length 55 cm | In distribution |
| 45673 | Outer Diameter 1.75 mm | In distribution |
| PKM61055314S | Catheter Gauge 4 Fr | In distribution |
| PKM61095323S | Catheter Gauge 5 Fr | In distribution |
| 60M181582 | Catheter Gauge 5 Fr | In distribution |
| 60M136992 | Single Lumen | In distribution |
| 60M140471 | Length 55 cm | In distribution |
| 60M163391 | Dual Lumen | In distribution |
| 60M137052 | Catheter Gauge 5 Fr | In distribution |
| PKM018396S | Dual | In distribution |
| PKM1949618S | Single | In distribution |
| 60M230141 | Catheter Gauge 5 Fr | In distribution |
| PKM060473S | Dual | In distribution |
| 45668 | Length 55 cm | In distribution |
| 60M033561 | Catheter Gauge 5 Fr | In distribution |
| 60M231602 | Length 55 cm | In distribution |
| 45716 | Outer Diameter 1.7 mm | In distribution |
| 60M130904 | Single Lumen | In distribution |
| 45657 | Length 55 cm | In distribution |
| PKM220187S | Dual | In distribution |
| PKMR61067724S | Triple | In distribution |
| 95247 | Needle Gauge 21 G | In distribution |
| 60M701532 | Dual Lumen | In distribution |
| 60M033562 | Catheter Gauge 5 Fr | In distribution |
| 60M122272 | Length 55 cm | In distribution |
| 45677 | Needle Gauge 21 G | In distribution |
| 60M019881 | Length 55 cm | In distribution |
| 60M195115 | Catheter Gauge 5 Fr | In distribution |
| 60M016581 | Length 55 cm | In distribution |
| 60M136723 | Dual Lumen | In distribution |
| PKM61016891S | Single | In distribution |
| 75001 | Length 55 cm | In distribution |
| 60M250122 | Dual Lumen | In distribution |
| 60M193583 | Single | In distribution |
| 25102 | Catheter Gauge 4 Fr | In distribution |
| 60M220541 | Dual Lumen | In distribution |
| 60M136993 | Triple Lumen | In distribution |
| PKM196044S | Catheter Gauge 4 Fr | In distribution |
| 45652 | Outer Diameter 1.4 mm | In distribution |
| 60M136991 | Dual Lumen | In distribution |
| PKM1949619S | Length 55 cm | In distribution |
| PKM1636015S | Catheter Gauge 4 Fr | In distribution |
| 55713 | Catheter Gauge 4 Fr | In distribution |
| 45737 | Needle Gauge 21 G | In distribution |
| 60M701531 | Length 55 cm | In distribution |
| 60M062342 | Catheter Gauge 5 Fr | In distribution |
| 25109 | Catheter Gauge 6 Fr | In distribution |
| 60M163691 | Length 55 cm | In distribution |
| 45675 | Length 55 cm | In distribution |
| 60M140472 | Length 55 cm | In distribution |
| 60M201951 | Catheter Gauge 5 Fr | In distribution |
| 60M183103 | Single Lumen | In distribution |
| 45744 | Outer Diameter 2.2 mm | In distribution |
| PKM130864S | Catheter Gauge 4 Fr | In distribution |
| PKM61090105S | Length 55 cm | In distribution |
| 60M010186 | Length 55 cm | In distribution |
| 25120 | Catheter Gauge 3 Fr | In distribution |
| 60M130903 | Single Lumen | In distribution |
| 60M162622 | Catheter Gauge 3 Fr | In distribution |
| 45742 | Outer Diameter 2.2 mm | In distribution |
| PKMR22233S | Catheter Gauge 5 Fr | In distribution |
| 45733 | Outer Diameter 1.75 mm | In distribution |
| PKM2301414S | Catheter Gauge 4 Fr | In distribution |
| PKM193585S | Length 45 cm | In distribution |
| 60M050111 | Catheter Gauge 4 Fr | In distribution |
| 60M161364 | Length 55 cm | In distribution |
| 60M163601 | Length 55 cm | In distribution |
| PKM130865S | Length 55 cm | In distribution |
| 60M080043 | Length 55 cm | In distribution |
| PKM61064541S | Single | In distribution |
| 60M190751 | Length 55 cm | In distribution |
| 60M231604 | Single Lumen | In distribution |
| 60M160434 | Catheter Gauge 5 Fr | In distribution |
| PKM3004831S | Catheter Gauge 5 Fr | In distribution |
| 60M062341 | Single Lumen | In distribution |
| 75-069 | Pressure 236 psi | In distribution |
| 60M231971 | Catheter Gauge 5 Fr | In distribution |
| PKM130862S | Length 55 cm | In distribution |
| 60M195053 | Length 55 cm | In distribution |
| 60M183102 | Catheter Gauge 4 Fr | In distribution |
| 60M3067601 | Catheter Gauge 5 Fr | In distribution |
| 25106 | Catheter Gauge 5 Fr | In distribution |
| 60M023825 | Catheter Gauge 4 Fr | In distribution |
| 60M159985 | Dual Lumen | In distribution |
| 60M137905 | Catheter Gauge 5 Fr | In distribution |
| 60M032783 | Single Lumen | In distribution |
| 25108 | Catheter Gauge 6 Fr | In distribution |
| 60M231601 | Catheter Gauge 5 Fr | In distribution |
| 60M184521 | Catheter Gauge 4 Fr | In distribution |
| 60M701372 | Catheter Gauge 5 Fr | In distribution |
| 60M3131641 | Length 55 cm | In distribution |
| 60M030393 | Catheter Gauge 5 Fr | In distribution |
| 60M195054 | Catheter Gauge 5 Fr | In distribution |
| 60M181373 | Catheter Gauge 5 Fr | In distribution |
| 60M014702 | Length 55 cm | In distribution |
| 75004 | Needle Gauge 21 G | In distribution |
| 60M120537 | Dual Lumen | In distribution |
| 60M021682 | Length 55 cm | In distribution |
| 45672 | Outer Diameter 1.75 mm | In distribution |
| 60M61016893 | Catheter Gauge 4 Fr | In distribution |
| 75002 | Needle Gauge 21 G | In distribution |
| 60M220542 | Catheter Gauge 6 Fr | In distribution |
| 60M220543 | Catheter Gauge 5 Fr | In distribution |
| 60M130905 | Length 55 cm | In distribution |
| 95242 | Needle Gauge 21 G | In distribution |
| 60M023903 | Single Lumen | In distribution |
| 60M194966 | Catheter Gauge 4 Fr | In distribution |
| 60M110912 | Length 55 cm | In distribution |
| PKM030894S | Length 55 cm | In distribution |
| 60M160433 | Single Lumen | In distribution |
| 60M122271 | Single Lumen | In distribution |
| 60M193882 | Single Lumen | In distribution |
| 55732 | Outer Diameter 1.75 mm | In distribution |
| 60M016967 | Single Lumen | In distribution |
| 60M150181 | Catheter Gauge 5 Fr | In distribution |
| 55731 | Catheter Gauge 5 Fr | In distribution |
| 25123 | Pressure 325 psi | In distribution |
| 60M163605 | Length 55 cm | In distribution |
| 60M220192 | Length 55 cm | In distribution |
| 25122 | Length 55 cm | In distribution |
| 60M195842 | Length 55 cm | In distribution |
| 60M161362 | Dual Lumen | In distribution |
| 60M195114 | Length 55 cm | In distribution |
| 60M184173 | Dual Lumen | In distribution |
| 60M050112 | Length 55 cm | In distribution |
| PKM018395S | Single | In distribution |
| PKM3036765S | Catheter Gauge 5 Fr | In distribution |
| 60M011611 | Dual Lumen | In distribution |
| 60M211485 | Length 55 cm | In distribution |
| 25101 | Catheter Gauge 4 Fr | In distribution |
| 60M211483 | Dual Lumen | In distribution |
| PKM131933S | Length 55 cm | In distribution |
| 45702 | Catheter Gauge 3 Fr | In distribution |
| 60M181583 | Triple Lumen | In distribution |
| 60M61016891 | Single | In distribution |
| 45676 | Outer Diameter 1.4 mm | In distribution |
| 60M041151 | Length 55 cm | In distribution |
| 60M190753 | Length 55 cm | In distribution |
| 25121 | Needle Gauge 21 G | In distribution |
| 45704 | Catheter Gauge 3 Fr | In distribution |
| 25125 | Needle Gauge 21 G | In distribution |
| 60M220191 | Dual Lumen | In distribution |
| 60M230104 | Catheter Gauge 5 Fr | In distribution |
| 95246 | Catheter Gauge 6 Fr | In distribution |
| 60M120194 | Catheter Gauge 5 Fr | In distribution |
| 60M110911 | Dual Lumen | In distribution |
| 45711 | Outer Diameter 1.4 mm | In distribution |
| 25129 | Length 55 cm | In distribution |
| 60M120195 | Length 55 cm | In distribution |
| 60M140123 | Catheter Gauge 5 Fr | In distribution |
| PKM196045S | Dual | In distribution |
| 60M194965 | Length 55 cm | In distribution |
| 45745 | Needle Gauge 21 G | In distribution |
| 60M159984 | Catheter Gauge 4 Fr | In distribution |
| PKM193589S | Length 45 cm | In distribution |
| 60M231605 | Catheter Gauge 5 Fr | In distribution |
| 60M140423 | Catheter Gauge 6 Fr | In distribution |
| 60M211484 | Length 55 cm | In distribution |
| 45713 | Length 55 cm | In distribution |
| PKM030652S | Length 55 cm | In distribution |
| 45732 | Needle Gauge 21 G | In distribution |
| 55711 | Outer Diameter 1.4 mm | In distribution |
| 60M010188 | Length 55 cm | In distribution |
| 60M023574 | Length 55 cm | In distribution |
| PKM61095321S | Catheter Gauge 4 Fr | In distribution |
| 60M121682 | Catheter Gauge 6 Fr | In distribution |
| 60M100922 | Length 55 cm | In distribution |
| 25126 | Catheter Gauge 5 Fr | In distribution |
| 60M011122 | Length 55 cm | In distribution |
| 60M090811 | Dual Lumen | In distribution |
| 45743 | Outer Diameter 2.2 mm | In distribution |
| 60M163604 | Single | In distribution |
| 60M130906 | Triple Lumen | In distribution |
| 25104 | Catheter Gauge 5 Fr | In distribution |
| 60M120193 | Single Lumen | In distribution |
| 60M030394 | Length 55 cm | In distribution |
| 45678 | Pressure 300 psi | In distribution |
| 55718 | Length 55 cm | In distribution |
| 60M193585 | Length 55 cm | In distribution |
| 60M210374 | Length 55 cm | In distribution |
| 60M210852 | Length 55 cm | In distribution |
| 60M136724 | Length 55 cm | In distribution |
| PKMR61067723S | Single | In distribution |
| 25124 | Length 55 cm | In distribution |
| 60M231033 | Triple Lumen | In distribution |
| 75-068 | Outer Diameter 1.4 mm | In distribution |
| PKM193587S | Catheter Gauge 4 Fr | In distribution |
| PKM033562S | Catheter Gauge 5 Fr | In distribution |
| 60M193584 | Dual | In distribution |
| 60M021684 | Length 55 cm | In distribution |
| PKMR61067721S | Dual | In distribution |
| PKM61055312S | Length 55 cm | In distribution |
| 25103 | Catheter Gauge 5 Fr | In distribution |
| 60M161368 | Length 55 cm | In distribution |
| PKM2301413S | Dual | In distribution |
| 55717 | Catheter Gauge 5 Fr | In distribution |
| 60M185471 | Length 55 cm | In distribution |
| 60M161365 | Length 55 cm | In distribution |
| 60M212082 | Length 55 cm | In distribution |
| 60M181374 | Catheter Gauge 4 Fr | In distribution |
| 60M121683 | Length 55 cm | In distribution |
| 60M3047691 | Length 55 cm | In distribution |
| 60M137051 | Catheter Gauge 4 Fr | In distribution |
| 60M186113 | Length 55 cm | In distribution |
| 60M161367 | Catheter Gauge 6 Fr | In distribution |
| 75-070 | Catheter Gauge 5 Fr | In distribution |
| 60M011121 | Single Lumen | In distribution |
| 60M030132 | Catheter Gauge 5 Fr | In distribution |
| 60M036762 | Dual Lumen | In distribution |
| PKMR61010891S | Catheter Gauge 4 Fr | In distribution |
| 55737 | Needle Gauge 21 G | In distribution |
| 45741 | Catheter Gauge 6 Fr | In distribution |
| 45715 | Pressure 325 psi | In distribution |
| 75-071 | Length 55 cm | In distribution |
| 75003 | Catheter Gauge 5 Fr | In distribution |
| 45734 | Outer Diameter 1.75 mm | In distribution |
| 95244 | Pressure 325 psi | In distribution |
| 60M100921 | Single Lumen | In distribution |
| 60M232593 | Catheter Gauge 4 Fr | In distribution |
| 45735 | Outer Diameter 1.75 mm | In distribution |
| PKMR22237S | Catheter Gauge 4 Fr | In distribution |
| 60M193586 | Length 55 cm | In distribution |
| 45705 | Outer Diameter 1.05 mm | In distribution |
| 45714 | Catheter Gauge 4 Fr | In distribution |
| 60M230142 | Length 55 cm | In distribution |
| 55733 | Length 55 cm | In distribution |
| 60M61016891 | Length 45 cm | In distribution |
| 45718 | Length 55 cm | In distribution |
| 60M184522 | Catheter Gauge 5 Fr | In distribution |
| 60M701371 | Length 55 cm | In distribution |
| 95243 | Length 55 cm | In distribution |
| 60M036261 | Length 55 cm | In distribution |
| 25105 | Pressure 300 psi | In distribution |
| 60M022795 | Single Lumen | In distribution |
| 60M161366 | Dual | In distribution |
Showing 250 of 271 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| 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.