Amecath Y split catheter

GUDID 06221139059644

Permthane Y split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 35 Cm total length 40 Cm

Ameco Medical Industries

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 06221139059644
• NIH Device Record Key: 5309ba45-fa02-4cd4-8d72-ea809730231f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amecath Y split catheter
• Version Model Number: PYDLC-1435-KPC
• 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: 35 Centimeter
• Catheter Gauge: 14 French
• Length: 35 Centimeter
• Catheter Gauge: 14 French
• Length: 35 Centimeter
• Catheter Gauge: 14 French
• Length: 35 Centimeter
• Catheter Gauge: 14 French
• Length: 35 Centimeter
• Catheter Gauge: 14 French
• Length: 35 Centimeter
• Catheter Gauge: 14 French
• Length: 35 Centimeter
• Catheter Gauge: 14 French
• Length: 35 Centimeter
• Catheter Gauge: 14 French
• Length: 35 Centimeter
• Catheter Gauge: 14 French
• Length: 35 Centimeter
• Catheter Gauge: 14 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	06221139059644 [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 Y split catheter]

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• 06221139123949: Permthane Y split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 3
• 06221139123932: Permthane Y split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 2
• 06221139123925: Permthane Y split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 2
• 06221139123918: Permthane Y split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 1
• 06221139123901: Permthane Y split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 35 Cm total
• 06221139123895: Permthane Y split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 31 Cm total
• 06221139123888: Permthane Y split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 27 Cm total
• 06221139123871: Permthane Y split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 23 Cm total
• 06221139123864: Permthane Y split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 19 Cm total
• 06221139110796: Permthane Y split Long term dual lumen catheter kit size 12 Fr tip to cuff length 15.5 Cm total
• 06221139110789: Permthane Y split Long term dual lumen catheter kit size 12 Fr tip to cuff length 19 Cm total le
• 06221139059651: Permthane Y split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 50
• 06221139059644: Permthane Y split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 35
• 06221139059637: Permthane Y split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 31
• 06221139059620: Permthane Y split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 27
• 06221139059613: Permthane Y split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 23
• 06221139059606: Permthane Y split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 19
• 06221139059590: Permthane Y split Long term dual lumen Pre-curved catheter kit size 12 Fr tip to cuff length 19
• 06221139059583: Permthane Y split Long term dual lumen Pre-curved catheter kit size 12 Fr tip to cuff length 15.
• 06221139059484: Permthane Y split Long term dual lumen catheter kit size 14 Fr tip to cuff length 50 Cm total le
• 06221139059477: Permthane Y split Long term dual lumen catheter kit size 14 Fr tip to cuff length 35 Cm total le
• 06221139059460: Permthane Y split Long term dual lumen catheter kit size 14 Fr tip to cuff length 31 Cm total le
• 06221139059453: Permthane Y split Long term dual lumen catheter kit size 14 Fr tip to cuff length 27 Cm total le
• 06221139059446: Permthane Y split Long term dual lumen catheter kit size 14 Fr tip to cuff length 23 Cm total le
• 06221139059439: Permthane Y split Long term dual lumen catheter kit size 14 Fr tip to cuff length 19 Cm total le