UniFuse

GUDID H787124018075

UniFuse Infusion System w/ Cooper Wire

ANGIODYNAMICS, INC.

Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

• Primary Device ID: H787124018075
• NIH Device Record Key: e8cc0d14-263e-4dcd-9fc9-c60d29892c3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniFuse
• Version Model Number: 12401807
• Company DUNS: 079105071
• 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(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 1.71 Millimeter
• Length: 90 Centimeter
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H787124018070 [Primary]
HIBCC	H787124018075 [Package]; Contains: H787124018070; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163356

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: 5
• Public Version Date: 2020-03-06
• Device Publish Date: 2016-09-19

On-Brand Devices [UniFuse]

• H787124018445: UniFuse Infusion System w/ Cooper Wire
• H787124018435: UniFuse Infusion System w/ Cooper Wire
• H787124018425: UniFuse Infusion System w/ Cooper Wire
• H787124018415: UniFuse Infusion System w/ Cooper Wire
• H787124018385: UniFuse Infusion System w/ Cooper Wire
• H787124018375: UniFuse Infusion System w/ Cooper Wire
• H787124018365: UniFuse Infusion System w/ Cooper Wire
• H787124018355: UniFuse Infusion System w/ Cooper Wire
• H787124018345: UniFuse Infusion System w/ Cooper Wire
• H787124018335: UniFuse Infusion System w/ Cooper Wire
• H787124018325: UniFuse Infusion System w/ Cooper Wire
• H787124018315: UniFuse Infusion System w/ Cooper Wire
• H787124018305: UniFuse Infusion System w/ Cooper Wire
• H787124018295: UniFuse Infusion System w/ Cooper Wire
• H787124018285: UniFuse Infusion System w/ Cooper Wire
• H787124018275: UniFuse Infusion System w/ Cooper Wire
• H787124018265: UniFuse Infusion System w/ Cooper Wire
• H787124018255: UniFuse Infusion System w/ Cooper Wire
• H787124018245: UniFuse Infusion System w/ Cooper Wire
• H787124018235: UniFuse Infusion System w/ Cooper Wire
• H787124018215: UniFuse Infusion System w/ Cooper Wire
• H787124018205: UniFuse Infusion System w/ Cooper Wire
• H787124018195: UniFuse Infusion System w/ Cooper Wire
• H787124018185: UniFuse Infusion System w/ Cooper Wire
• H787124018175: UniFuse Infusion System w/ Cooper Wire
• H787124018165: UniFuse Infusion System w/ Cooper Wire
• H787124018155: UniFuse Infusion System w/ Cooper Wire
• H787124018145: UniFuse Infusion System w/ Cooper Wire
• H787124018135: UniFuse Infusion System w/ Cooper Wire
• H787124018125: UniFuse Infusion System w/ Cooper Wire
• H787124018115: UniFuse Infusion System w/ Cooper Wire
• H787124018105: UniFuse Infusion System w/ Cooper Wire
• H787124018095: UniFuse Infusion System w/ Cooper Wire
• H787124018085: UniFuse Infusion System w/ Cooper Wire
• H787124018065: UniFuse Infusion System w/ Cooper Wire
• H787124018055: UniFuse Infusion System w/ Cooper Wire
• H787124018045: UniFuse Infusion System w/ Cooper Wire
• H787124018035: UniFuse Infusion System w/ Cooper Wire
• H787124018025: UniFuse Infusion System w/ Cooper Wire
• H787124018015: UniFuse Infusion System w/ Cooper Wire
• H787124018225: UniFuse Infusion System w/ Cooper Wire
• H787124018075: UniFuse Infusion System w/ Cooper Wire