Accu-Vu

GUDID H787137099200

Accu-Vu Angiographic Catheter, Straight Flush, Non-Braided

ANGIODYNAMICS, INC.

Angiographic catheter, single-use

• Primary Device ID: H787137099200
• NIH Device Record Key: 56178dcf-9c1e-41f3-a5f3-089915d2c1d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Vu
• Version Model Number: 13709920
• 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

Device Dimensions

• Outer Diameter: 1.8 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684006125 [Secondary]
HIBCC	H787137099200 [Primary]
HIBCC	H787137099205 [Package]; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161596

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

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: 2018-12-19
• Device Publish Date: 2018-01-23

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