Amecath dual lumen catheter

GUDID 06221139058753

Permthane Long term dual lumen catheter kit size 14 Fr tip to cuff length 23 Cm total length 28 Cm

Ameco Medical Industries

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 06221139058753
• NIH Device Record Key: c7d555b8-7fee-460a-92d8-0855b1c8a07d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amecath dual lumen catheter
• Version Model Number: PDLC-1423-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

• Length: 23 Centimeter
• Catheter Gauge: 14 French
• Length: 23 Centimeter
• Catheter Gauge: 14 French
• Length: 23 Centimeter
• Catheter Gauge: 14 French
• Length: 23 Centimeter
• Catheter Gauge: 14 French
• Length: 23 Centimeter
• Catheter Gauge: 14 French
• Length: 23 Centimeter
• Catheter Gauge: 14 French
• Length: 23 Centimeter
• Catheter Gauge: 14 French
• Length: 23 Centimeter
• Catheter Gauge: 14 French
• Length: 23 Centimeter
• Catheter Gauge: 14 French
• Length: 23 Centimeter
• Catheter Gauge: 14 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	06221139058753 [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

On-Brand Devices [Amecath dual lumen catheter]

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• 06221139123826: Permthane Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 23 Cm tot
• 06221139123819: Permthane Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 19 Cm tot
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• 06221139123772: Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 23 Cm total length 2
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• 06221139058937: Permthane Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 27 Cm total
• 06221139058920: Permthane Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 23 Cm total
• 06221139058913: Permthane Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 19 Cm total
• 06221139058906: Permthane Long term dual lumen Pre-curved catheter kit size 12 Fr tip to cuff length 19 Cm total
• 06221139058890: Permthane Long term dual lumen Pre-curved catheter kit size 12 Fr tip to cuff length 15.5 Cm tot
• 06221139058791: Permthane Long term dual lumen catheter kit size 14 Fr tip to cuff length 50 Cm total length 55
• 06221139058784: Permthane Long term dual lumen catheter kit size 14 Fr tip to cuff length 35 Cm total length 40
• 06221139058777: Permthane Long term dual lumen catheter kit size 14 Fr tip to cuff length 31 Cm total length 36
• 06221139058760: Permthane Long term dual lumen catheter kit size 14 Fr tip to cuff length 27 Cm total length 32
• 06221139058753: Permthane Long term dual lumen catheter kit size 14 Fr tip to cuff length 23 Cm total length 28
• 06221139058746: Permthane Long term dual lumen catheter kit size 14 Fr tip to cuff length 19 Cm total length 24
• 06221139058739: Permthane Long term dual lumen catheter kit size 12 Fr tip to cuff length 19 Cm total length 24
• 06221139058722: Permthane Long term dual lumen catheter kit size 12 Fr tip to cuff length 16 Cm total length 21