Xcela
GUDID H965440290
Xcela Plus Plastic Port with Non-Filled Suture Holes and 6F x 63cm Polyurethane Catheter
NAVILYST MEDICAL, INC.
Infusion/injection port, implantable| Primary Device ID | H965440290 |
| NIH Device Record Key | eddd90fb-ee08-4cc6-8cbb-4a2a0931f43e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xcela |
| Version Model Number | 44029 |
| Company DUNS | 809699023 |
| Company Name | NAVILYST MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Length | 63 Centimeter |
| Pressure | 300 Pound per Square Inch |
| Needle Gauge | 18 Gauge |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Outer Diameter | 2.1 Millimeter |
| Catheter Gauge | 6 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Catheter Gauge | 6 French |
| Outer Diameter | 2.1 Millimeter |
| Length | 63 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684018791 [Secondary] |
| HIBCC | H965440290 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153228
FDA Product Code
| LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [Xcela]
| H965PKM61095323S1 | PICC Convenience Kit |
| H96560M2120821 | PICC Convenience Kit |
| H965750710 | Xcela Power Injectable PICC (6F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nu |
| H965750700 | Xcela Power Injectable PICC (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nu |
| H965750690 | Xcela Power Injectable PICC (5F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape |
| H965750680 | Xcela Power Injectable PICC (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape |
| H965440430 | Xcela Plus Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 8F x 63cm Poly |
| H965440410 | Xcela Plus Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Poly |
| H965440400 | Xcela Plus Plastic Port with PASV Valve Technology (Filled Suture Holes) and 8F x 63cm Polyureth |
| H965440390 | Xcela Plus Plastic Port with PASV Valve Technology (Non-Filled Suture Holes) and 8F x 63cm Polyu |
| H965440380 | Xcela Plus Plastic Port with PASV Valve Technology (Filled Suture Holes) and 6F x 63cm Polyureth |
| H965440370 | Xcela Plus Plastic Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Polyu |
| H965440350 | Xcela Plus Titanium Port with Non-Filled Suture Holes and 8F x 63cm Polyurethane Catheter |
| H965440330 | Xcela Plus Titanium Port with Non-Filled Suture Holes and 6F x 63cm Polyurethane Catheter |
| H965440320 | Xcela Plus Plastic Port with Filled Suture Holes and 8F x 63cm Polyurethane Catheter |
| H965440310 | Xcela Plus Plastic Port with Non-Filled Suture Holes and 8F x 63cm Polyurethane Catheter |
| H965440300 | Xcela Plus Plastic Port with Filled Suture Holes and 6F x 63cm Polyurethane Catheter |
| H965440290 | Xcela Plus Plastic Port with Non-Filled Suture Holes and 6F x 63cm Polyurethane Catheter |
| H96560M1404720 | PICC Convenience Kit |
| H96560M1404711 | PICC Convenience Kit |
| H96560M1404231 | PICC Convenience Kit |
| H96560M1401231 | PICC Convenience Kit |
| H96560M1379051 | PICC Convenience Kit |
| H96560M1369931 | PICC Convenience Kit |
| H96560M1369921 | PICC Convenience Kit |
| H96560M1369911 | PICC Convenience Kit |
| H96560M1367241 | PICC Convenience Kit |
| H96560M1367231 | PICC Convenience Kit |
| H96560M1309061 | PICC Convenience Kit |
| H96560M1309051 | PICC Convenience Kit |
| H96560M1309041 | PICC Convenience Kit |
| H96560M1309031 | PICC Convenience Kit |
| H96560M1216831 | PICC Convenience Kit |
| H96560M1216821 | PICC Convenience Kit |
| H96560M1216811 | PICC Convenience Kit |
| H96560M1205371 | PICC Convenience Kit |
| H96560M1201951 | PICC Convenience Kit |
| H96560M1201941 | PICC Convenience Kit |
| H96560M1201931 | PICC Convenience Kit |
| H96560M1109121 | PICC Convenience Kit |
| H96560M1009221 | PICC Convenience Kit |
| H96560M1009211 | PICC Convenience Kit |
| H96560M0908111 | PICC Convenience Kit |
| H96560M0800431 | PICC Convenience Kit |
| H96560M0623421 | PICC Convenience Kit |
| H96560M0623411 | PICC Convenience Kit |
| H96560M0501131 | PICC Convenience Kit |
| H96560M0501121 | PICC Convenience Kit |
| H96560M0501111 | PICC Convenience Kit |
| H96560M0411511 | PICC Convenience Kit |
Trademark Results [Xcela]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XCELA 98560873 not registered Live/Pending |
Xcela, Inc. 2024-05-21 |
 XCELA 86456391 not registered Live/Pending |
Essenlix Corporation 2014-11-17 |
 XCELA 77082290 3363005 Live/Registered |
NAVILYST MEDICAL, INC. 2007-01-12 |
 XCELA 74130696 not registered Dead/Abandoned |
Kirschner, Alexander 1991-01-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.