D*Clot® HD Rotational Thrombectomy System T10106040

GUDID 15711055004326

The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts

Mermaid Medical A/S

Thrombectomy rotational catheter

• Primary Device ID: 15711055004326
• NIH Device Record Key: 7024f4df-7925-437a-af36-975da7b95e14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D*Clot® HD Rotational Thrombectomy System
• Version Model Number: D*Clot® HD 6Fx40CM
• Catalog Number: T10106040
• Company DUNS: 308951313
• Company Name: Mermaid Medical A/S
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Dimensions

• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 40 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05711055004329 [Package]; Package: Shelfbox [1 Units]; In Commercial Distribution
GS1	15711055004326 [Primary]

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-24
• Device Publish Date: 2020-03-16

On-Brand Devices [D*Clot® HD Rotational Thrombectomy System]

• 15711055004333: The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of nativ
• 15711055004326: The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of nativ