Voss Coronary Bypass Vein Flushing Cannula

GUDID 00811304020096

Coronary Bypass Vein Flushing Cannula (non-sterile)

VM CARDIO VASCULAR, INC.

Vascular irrigation cannula, coronary artery, single-use

• Primary Device ID: 00811304020096
• NIH Device Record Key: 8b40045b-6210-47c8-8621-a325c8ba3e7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Voss Coronary Bypass Vein Flushing Cannula
• Version Model Number: 82609-NS
• Company DUNS: 799240457
• Company Name: VM CARDIO VASCULAR, 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811304020096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896338

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00811304020096]

Ethylene Oxide

[00811304020096]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-01-05

On-Brand Devices [Voss Coronary Bypass Vein Flushing Cannula]

• 00811304020096: Coronary Bypass Vein Flushing Cannula (non-sterile)
• 00811304020065: Vein flushing Cannula for Coronary Bypass (sterile)