Amecath X split catheter

GUDID 06221139124069

Permthane X split Long term dual lumen catheter kit size 15.5 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: 06221139124069
• NIH Device Record Key: c3262e57-fb57-418c-bed4-d2a7a234cd81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amecath X split catheter
• Version Model Number: PXDLC-15.519-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: 19 Centimeter
• Catheter Gauge: 15.5 French
• Length: 19 Centimeter
• Catheter Gauge: 15.5 French
• Length: 19 Centimeter
• Catheter Gauge: 15.5 French
• Length: 19 Centimeter
• Catheter Gauge: 15.5 French
• Length: 19 Centimeter
• Catheter Gauge: 15.5 French
• Length: 19 Centimeter
• Catheter Gauge: 15.5 French
• Length: 19 Centimeter
• Catheter Gauge: 15.5 French
• Length: 19 Centimeter
• Catheter Gauge: 15.5 French
• Length: 19 Centimeter
• Catheter Gauge: 15.5 French
• Length: 19 Centimeter
• Catheter Gauge: 15.5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	06221139124069 [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 X split catheter]

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• 06221139124106: Permthane X split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 35 Cm total
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• 06221139124076: Permthane X split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 23 Cm total
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• 06221139059262: Permthane X split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 23
• 06221139059255: Permthane X split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 19
• 06221139059248: Permthane X split Long term dual lumen Pre-curved catheter kit size 12 Fr tip to cuff length 19
• 06221139059231: Permthane X split Long term dual lumen Pre-curved catheter kit size 12 Fr tip to cuff length 15.
• 06221139059132: Permthane X split Long term dual lumen catheter kit size 14 Fr tip to cuff length 50 Cm total le
• 06221139059125: Permthane X split Long term dual lumen catheter kit size 14 Fr tip to cuff length 35 Cm total le
• 06221139059118: Permthane X split Long term dual lumen catheter kit size 14 Fr tip to cuff length 31 Cm total le
• 06221139059101: Permthane X split Long term dual lumen catheter kit size 14 Fr tip to cuff length 27 Cm total le
• 06221139059095: Permthane X split Long term dual lumen catheter kit size 14 Fr tip to cuff length 23 Cm total le
• 06221139059088: Permthane X split Long term dual lumen catheter kit size 14 Fr tip to cuff length 19 Cm total le
• 06221139059071: Permthane X split Long term dual lumen catheter kit size 12 Fr tip to cuff length 19 Cm total le
• 06221139059064: Permthane X split Long term dual lumen catheter kit size 12 Fr tip to cuff length 15.5 Cm total
• 06221139070045: Permthane X split Long term dual lumen catheter kit size 14 Fr tip to cuff length 31 Cm total le