DuraFlow

GUDID H787103012015

DuraFlow 2 - 15.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip)

ANGIODYNAMICS, INC.

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: H787103012015
• NIH Device Record Key: 734a0346-68f2-4e69-aaf2-ec9cc27cc1a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraFlow
• Version Model Number: 10301201
• 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
• 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

• Length: 24 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 15.5 French
• Length: 24 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 15.5 French
• Length: 24 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 15.5 French
• Length: 24 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 15.5 French
• Length: 24 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 15.5 French
• Length: 24 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 15.5 French
• Length: 24 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 15.5 French
• Length: 24 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 15.5 French
• Length: 24 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 15.5 French
• Length: 24 Centimeter

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
• 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
GS1	15051684014731 [Secondary]
HIBCC	H787103012010 [Primary]
HIBCC	H787103012011 [Package]; Contains: H787103012010; Package: BOX [1 Units]; In Commercial Distribution
HIBCC	H787103012015 [Package]; Contains: H787103012010; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110936

FDA Product Code

• MSD: Catheter, hemodialysis, implanted

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: 2019-02-12
• Device Publish Date: 2015-09-15

On-Brand Devices [DuraFlow]

• H787103018015: HemoDialysis Catheter Repair Kit
• H787103017155: DuraFlow 2 - 15.5F x 48cm DuraFlow2 Hemodialysis Catheter (with Cuff 43cm from Tip)
• H787103017145: DuraFlow 2 - 15.5F x 55cm DuraFlow2 Hemodialysis Catheter (with Cuff 50cm from Tip)
• H787103017135: DuraFlow 2 - 15.5F x 22cm DuraFlow2 Hemodialysis Catheter (with Cuff 17cm from Tip)
• H787103017115: DuraFlow 2 - 15.5F x 20cm DuraFlow2 Hemodialysis Catheter (with Cuff 15cm from Tip)
• H787103017055: DuraFlow 2 - 15.5F x 40cm DuraFlow2 Hemodialysis Catheter (with Cuff 35cm from Tip)
• H787103017045: DuraFlow 2 - 15.5F x 36cm DuraFlow2 Hemodialysis Catheter (with Cuff 31cm from Tip)
• H787103017035: DuraFlow 2 - 15.5F x 32cm DuraFlow2 Hemodialysis Catheter (with Cuff 27cm from Tip)
• H787103017025: DuraFlow 2 - 15.5F x 28cm DuraFlow2 Hemodialysis Catheter (with Cuff 23cm from Tip)
• H787103017015: DuraFlow 2 - 15.5F x 24cm DuraFlow2 Hemodialysis Catheter (with Cuff 19cm from Tip)
• H787103014035: Dura-Flow Tunneling Trocar
• H787103012245: DuraFlow 2 - 15.5F x 55cm Chronic Hemodialysis VascPak Kit (with Cuff 50cm from Tip)
• H787103012235: DuraFlow 2 - 15.5F x 48cm Chronic Hemodialysis VascPak Kit (with Cuff 43cm from Tip)
• H787103012225: DuraFlow 2 - 15.5F x 40cm Chronic Hemodialysis VascPak Kit (with Cuff 35cm from Tip)
• H787103012215: DuraFlow 2 - 15.5F x 36cm Chronic Hemodialysis VascPak Kit (with Cuff 31cm from Tip)
• H787103012205: DuraFlow 2 - 15.5F x 32cm Chronic Hemodialysis VascPak Kit (with Cuff 27cm from Tip)
• H787103012195: DuraFlow 2 - 15.5F x 28cm Chronic Hemodialysis VascPak Kit (with Cuff 23cm from Tip)
• H787103012185: DuraFlow 2 - 15.5F x 24cm Chronic Hemodialysis VascPak Kit (with Cuff 19cm from Tip)
• H787103012175: DuraFlow 2 - 15.5F x 22cm Chronic Hemodialysis VascPak Kit (with Cuff 17cm from Tip)
• H787103012165: DuraFlow 2 - 15.5F x 20cm Chronic Hemodialysis VascPak Kit (with Cuff 15cm from Tip)
• H787103012155: DuraFlow 2 - 15.5F x 48cm Chronic Hemodialysis Catheter Set (with Cuff 43cm from Tip)
• H787103012145: DuraFlow 2 - 15.5F x 20cm Chronic Hemodialysis Catheter Set (with Cuff 15cm from Tip)
• H787103012135: 15.5F x 20cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 15cm from
• H787103012125: DuraFlow 2 - 15.5F x 22cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip)
• H787103012115: DuraFlow 2 - 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip)
• H787103012095: 15.5F x 36cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 31cm from
• H787103012085: 15.5F x 32cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 27cm from
• H787103012075: 15.5F x 28cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 23cm from
• H787103012065: 15.5F x 24cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 19cm from
• H787103012055: DuraFlow 2 - 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip)
• H787103012045: DuraFlow 2 - 15.5F x 36cm Chronic Hemodialysis Catheter Set (with Cuff 31cm from Tip)
• H787103012035: DuraFlow 2 - 15.5F x 32cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip)
• H787103012025: DuraFlow 2 - 15.5F x 28cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip)
• H787103012015: DuraFlow 2 - 15.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip)
• H787103011085: 15.5F x 32cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 27cm from
• H787103011035: 15.5F x 32cm Dura-Flow with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 27cm from Tip)
• H787103011025: 15.5F x 28cm Dura-Flow with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 23cm from Tip)
• H787103011015: 15.5F x 24cm Dura-Flow with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 19cm from Tip)
• H787103003015: 7F Double Access Hemodialysis Set