DuraMax

GUDID H787103028235

15.5F x 48cm Chronic Hemodialysis VascPak Kit (with Cuff 43cm from Tip)

ANGIODYNAMICS, INC.

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: H787103028235
• NIH Device Record Key: 414b8833-2693-4ce7-a1ff-b803bddbbef5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraMax
• Version Model Number: 10302823
• 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

• Catheter Gauge: 15.5 French
• Length: 48 Centimeter
• Catheter Gauge: 15.5 French
• Length: 48 Centimeter
• Catheter Gauge: 15.5 French
• Length: 48 Centimeter
• Catheter Gauge: 15.5 French
• Length: 48 Centimeter
• Catheter Gauge: 15.5 French
• Length: 48 Centimeter
• Catheter Gauge: 15.5 French
• Length: 48 Centimeter
• Catheter Gauge: 15.5 French
• Length: 48 Centimeter
• Catheter Gauge: 15.5 French
• Length: 48 Centimeter
• Catheter Gauge: 15.5 French
• Length: 48 Centimeter
• Catheter Gauge: 15.5 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
• 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	15051684011976 [Secondary]
HIBCC	H787103028230 [Primary]
HIBCC	H787103028235 [Package]; Contains: H787103028230; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101843

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 [DuraMax]

• H787103028205: 15.5F x 32cm Chronic Hemodialysis VascPak Kit (with Cuff 27cm from Tip)
• H787103028191: 15.5F x 28cm Chronic Hemodialysis VascPak Kit (with Cuff 23cm from Tip)
• H787103028185: 15.5F x 24cm Chronic Hemodialysis VascPak Kit (with Cuff 19cm from Tip)
• H787103028095: 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip)
• H787103028085: 15.5F x 48cm Chronic Hemodialysis Catheter Set (with Cuff 43cm from Tip)
• H787103028075: 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip)
• H787103028061: 15.5F x 36cm Chronic Hemodialysis Catheter Set (with Cuff 31cm from Tip)
• H787103028041: 15.5F x 28cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip)
• H787103028031: 15.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip)
• H787103028055: 15.5F x 32cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip)
• H787103029095: 15.5F x 55cm DuraMax Hemodialysis Catheter (with Cuff 50cm from the Tip)
• H787103029085: 15.5F x 48cm DuraMax Hemodialysis Catheter (with Cuff 43cm from the Tip)
• H787103029075: 15.5F x 40cm DuraMax Hemodialysis Catheter (with Cuff 35cm from the Tip)
• H787103029065: 15.5F x 36cm DuraMax Hemodialysis Catheter (with Cuff 31cm from the Tip)
• H787103029055: 15.5F x 32cm DuraMax Hemodialysis Catheter (with Cuff 27cm from the Tip)
• H787103029041: 15.5F x 28cm DuraMax Hemodialysis Catheter (with Cuff 23cm from the Tip)
• H787103029035: 15.5F x 24cm DuraMax Hemodialysis Catheter (with Cuff 19cm from the Tip)
• H787103029025: 15.5F x 22cm DuraMax Hemodialysis Catheter (with Cuff 17cm from the Tip)
• H787103029015: 15.5F x 20cm DuraMax Hemodialysis Catheter (with Cuff 15cm from the Tip)
• H787103028245: 15.5F x 55cm Chronic Hemodialysis VascPak Kit (with Cuff 50cm from Tip)
• H787103028235: 15.5F x 48cm Chronic Hemodialysis VascPak Kit (with Cuff 43cm from Tip)
• H787103028225: 15.5F x 40cm Chronic Hemodialysis VascPak Kit (with Cuff 35cm from Tip)
• H787103028215: 15.5F x 36cm Chronic Hemodialysis VascPak Kit (with Cuff 31cm from Tip)
• H787103028175: 15.5F x 22cm Chronic Hemodialysis VascPak Kit (with Cuff 17cm from Tip)
• H787103028165: 15.5F x 20cm Chronic Hemodialysis VascPak Kit (with Cuff 15cm from Tip)
• H787103028025: 15.5F x 22cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip)
• H787103028015: 15.5F x 20cm Chronic Hemodialysis Catheter Set (with Cuff 15cm from Tip)