Xcela

GUDID 15051684018890

Xcela Plus Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Polyurethane Catheter

Angiodynamics, Inc.

Vascular port/catheter

• Primary Device ID: 15051684018890
• NIH Device Record Key: f71cba13-6561-49fe-92d5-84eac7882ddf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xcela
• Version Model Number: 44041
• 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
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com

Device Dimensions

• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Lumen/Inner Diameter: 1.3 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684018890 [Primary]
HIBCC	H965440410 [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