Amecath Twincath catheter

GUDID 06221139059767

Permthane Twin Long term dual lumen catheter kit size 12 Fr tip to cuff length 19 Cm total length 24 Cm

Ameco Medical Industries

Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 06221139059767
• NIH Device Record Key: 9e6410c6-7555-4e8e-a7ce-0de2f68e7de3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amecath Twincath catheter
• Version Model Number: P2TC-1219-K
• Company DUNS: 565404779
• Company Name: Ameco Medical Industries
• 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: true
• 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: 2038804091
• Email: ray.k@arazygroup.com
• Phone: 2038804091
• Email: ray.k@arazygroup.com
• Phone: 2038804091
• Email: ray.k@arazygroup.com
• Phone: 2038804091
• Email: ray.k@arazygroup.com
• Phone: 2038804091
• Email: ray.k@arazygroup.com
• Phone: 2038804091
• Email: ray.k@arazygroup.com
• Phone: 2038804091
• Email: ray.k@arazygroup.com
• Phone: 2038804091
• Email: ray.k@arazygroup.com
• Phone: 2038804091
• Email: ray.k@arazygroup.com
• Phone: 2038804091
• Email: ray.k@arazygroup.com

Device Dimensions

• Catheter Gauge: 12 French
• Length: 19 Centimeter
• Catheter Gauge: 12 French
• Length: 19 Centimeter
• Catheter Gauge: 12 French
• Length: 19 Centimeter
• Catheter Gauge: 12 French
• Length: 19 Centimeter
• Catheter Gauge: 12 French
• Length: 19 Centimeter
• Catheter Gauge: 12 French
• Length: 19 Centimeter
• Catheter Gauge: 12 French
• Length: 19 Centimeter
• Catheter Gauge: 12 French
• Length: 19 Centimeter
• Catheter Gauge: 12 French
• Length: 19 Centimeter
• Catheter Gauge: 12 French
• Length: 19 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06221139059767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131814

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: 2018-07-06
• Device Publish Date: 2014-07-31

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