Xcela
GUDID 15051684018845
Xcela Plus Titanium Port with Non-Filled Suture Holes and 8F x 63cm Polyurethane Catheter
Angiodynamics, Inc.
Vascular port/catheter| Primary Device ID | 15051684018845 |
| NIH Device Record Key | 1103fcb2-6b3e-4cc9-be60-cef1930db6f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xcela |
| Version Model Number | 44035 |
| Company DUNS | 079252781 |
| Company Name | Angiodynamics, 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
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com |
Device Dimensions
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Outer Diameter | 2.6 Millimeter |
| Lumen/Inner Diameter | 1.6 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684018845 [Primary] |
| HIBCC | H965440350 [Previous] |
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-30 |
| Device Publish Date | 2024-09-20 |
On-Brand Devices [Xcela]
| 15051684018890 | Xcela Plus Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Poly |
| 15051684018876 | Xcela Plus Plastic Port with PASV Valve Technology (Non-Filled Suture Holes) and 8F x 63cm Polyu |
| 15051684018869 | Xcela Plus Plastic Port with PASV Valve Technology (Filled Suture Holes) and 6F x 63cm Polyureth |
| 15051684018852 | Xcela Plus Plastic Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Polyu |
| 15051684018845 | Xcela Plus Titanium Port with Non-Filled Suture Holes and 8F x 63cm Polyurethane Catheter |
| 15051684018821 | Xcela Plus Plastic Port with Filled Suture Holes and 8F x 63cm Polyurethane Catheter |
| 15051684018807 | Xcela Plus Plastic Port with Filled Suture Holes and 6F x 63cm Polyurethane Catheter |
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 |
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