Angel Catheter

GUDID B077AC3930A1

The Angel® Catheter combines the functions of a retrievable inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC).

BIO2 MEDICAL INC

Vena cava filter, temporary/permanent

• Primary Device ID: B077AC3930A1
• NIH Device Record Key: de9ecea1-fcc3-481f-a0d1-efa506aa9031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Angel Catheter
• Version Model Number: AC3930A
• Company DUNS: 019935020
• Company Name: BIO2 MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com
• Phone: +4547108570
• Email: customer@mermaidmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B077AC3930A1 [Primary]
HIBCC	B077AC3930A5 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160747

FDA Product Code

• PNS: Short-Term Intravascular Filter Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-18
• Device Publish Date: 2016-09-09