Uni-Fuse+

GUDID H787124018490

Uni-Fuse+ Infusion System 5F, 135cm, 10cm

Angiodynamics, Inc.

Peripheral vascular intervention infusion catheter

• Primary Device ID: H787124018490
• NIH Device Record Key: 7564a897-e62c-455c-974a-12934a05581f
• Commercial Distribution Discontinuation: 2024-07-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Uni-Fuse+
• Version Model Number: 12401849
• Company DUNS: 079252781
• Company Name: Angiodynamics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 135 Centimeter
• Catheter Gauge: 5 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H787124018490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202347

FDA Product Code

• KRA: Catheter, continuous flush

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-30
• Device Publish Date: 2020-10-30

On-Brand Devices [Uni-Fuse+]

• 15051684023955: Uni-Fuse+ Infusion System 5F, 135cm, 15cm
• 15051684023948: Uni-Fuse+ Infusion System 5F, 135cm, 2cm
• 15051684023931: Uni-Fuse+ Infusion System 5F, 90cm, 15cm
• 15051684023924: Uni-Fuse+ Infusion System 5F, 90cm, 2cm
• 15051684023917: Uni-Fuse+ Infusion System 4.3F, 135cm, 15cm
• 15051684023900: Uni-Fuse+ Infusion System 4.3F, 135cm, 2cm
• 15051684023894: Uni-Fuse+ Infusion System 4.3F, 90cm, 15cm
• 15051684023887: Uni-Fuse+ Infusion System 4.3F, 90cm, 2cm
• 15051684023870: Uni-Fuse+ Infusion System 4.3F, 135cm, 10cm
• 15051684023863: Uni-Fuse+ Infusion System 4.3F, 135cm, 5cm
• 15051684023856: Uni-Fuse+ Infusion System 4.3F, 90cm, 10cm
• 15051684023849: Uni-Fuse+ Infusion System 4.3F, 90cm, 5cm
• 15051684023832: Uni-Fuse+ Infusion System 5F, 135cm, 10cm
• 15051684023825: Uni-Fuse+ Infusion System 5F, 135cm, 5cm
• 15051684023818: Uni-Fuse+ Infusion System 5F, 90cm, 10cm
• 15051684023801: Uni-Fuse+ Infusion System 5F, 90cm, 5cm
• H787124018640: Uni-Fuse+ Infusion System 5F, 135cm, 15cm
• H787124018630: Uni-Fuse+ Infusion System 5F, 135cm, 2cm
• H787124018620: Uni-Fuse+ Infusion System 5F, 90cm, 15cm
• H787124018610: Uni-Fuse+ Infusion System 5F, 90cm, 2cm
• H787124018600: Uni-Fuse+ Infusion System 4.3F, 135cm, 15cm
• H787124018590: Uni-Fuse+ Infusion System 4.3F, 135cm, 2cm
• H787124018580: Uni-Fuse+ Infusion System 4.3F, 90cm, 15cm
• H787124018570: Uni-Fuse+ Infusion System 4.3F, 90cm, 2cm
• H787124018550: Uni-Fuse+ Infusion System 4.3F, 135cm, 10cm
• H787124018540: Uni-Fuse+ Infusion System 4.3F, 135cm, 5cm
• H787124018520: Uni-Fuse+ Infusion System 4.3F, 90cm, 10cm
• H787124018510: Uni-Fuse+ Infusion System 4.3F, 90cm, 5cm
• H787124018490: Uni-Fuse+ Infusion System 5F, 135cm, 10cm
• H787124018480: Uni-Fuse+ Infusion System 5F, 135cm, 5cm
• H787124018460: Uni-Fuse+ Infusion System 5F, 90cm, 10cm
• H787124018450: Uni-Fuse+ Infusion System 5F, 90cm, 5cm