EvenMore

GUDID H787103035035

14.5F x 32cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip)

ANGIODYNAMICS, INC.

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• Primary Device ID: H787103035035
• NIH Device Record Key: 0858938d-43e8-42f7-82d8-86defe26970f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EvenMore
• Version Model Number: 10303503
• 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
• 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
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 French
• Length: 32 Centimeter
• Needle Gauge: 18 Gauge
• Catheter Gauge: 14.5 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
• 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
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684014274 [Secondary]
HIBCC	H787103035030 [Primary]
HIBCC	H787103035035 [Package]; Contains: H787103035030; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040402

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: 3
• Public Version Date: 2019-04-25
• Device Publish Date: 2015-09-15

On-Brand Devices [EvenMore]

• H787103036065: 14.5F x 55cm EvenMore Straight Hemodialysis Catheter (with Cuff 50cm from Tip)
• H787103036035: 14.5F x 32cm EvenMore Straight Hemodialysis Catheter (with Cuff 27cm from Tip)
• H787103036025: 14.5F x 28cm EvenMore Straight Hemodialysis Catheter (with Cuff 23cm from Tip)
• H787103036015: 14.5F x 24cm EvenMore Straight Hemodialysis Catheter (with Cuff 19cm from Tip)
• H787103035125: 14.5F x 22cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip)
• H787103035115: 14.5F x 20cm Chronic Hemodialysis Catheter Set (with Cuff 15cm from Tip)
• H787103035105: 14.5F x 36cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 31cm from Tip)
• H787103035095: 14.5F x 32cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 27cm from Tip)
• H787103035085: 14.5F x 28cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 23cm from Tip)
• H787103035075: 14.5F x 24cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 19cm from Tip)
• H787103035055: 14.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip)
• H787103035035: 14.5F x 32cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip)
• H787103035025: 14.5F x 28cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip)
• H787103035015: 14.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip)
• H787103035065: 14.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip)
• H787103035045: 14.5F x 36cm Chronic Hemodialysis Catheter Set (with Cuff 31cm from Tip)
• H787103036125: 14.5F x 22cm EvenMore Straight Hemodialysis Catheter (with Cuff 17cm from Tip)
• H787103036115: 14.5F x 20cm EvenMore Straight Hemodialysis Catheter (with Cuff 15cm from Tip)
• H787103036105: 14.5F x 36cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 31cm from Tip)
• H787103036095: 14.5F x 32cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 27cm from Tip)
• H787103036085: 14.5F x 28cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 23cm from Tip)
• H787103036075: 14.5F x 24cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 19cm from Tip)
• H787103036055: 14.5F x 40cm EvenMore Straight Hemodialysis Catheter (with Cuff 35cm from Tip)
• H787103036045: 14.5F x 36cm EvenMore Straight Hemodialysis Catheter (with Cuff 31cm from Tip)