Amecath X split catheter

GUDID 06221139059248

Permthane X split Long term dual lumen Pre-curved 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	06221139059248
NIH Device Record Key	7a124ff1-6527-49cb-a5bb-e81a4b8fa3bd
Commercial Distribution Status	In Commercial Distribution
Brand Name	Amecath X split catheter
Version Model Number	PXDLC-1219-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

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	06221139059248 [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]

06221139124151	Permthane X split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 3
06221139124144	Permthane X split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 3
06221139124137	Permthane X split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 2
06221139124120	Permthane X split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 2
06221139124113	Permthane X split Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 1
06221139124106	Permthane X split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 35 Cm total
06221139124090	Permthane X split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 31 Cm total
06221139124083	Permthane X split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 27 Cm total
06221139124076	Permthane X split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 23 Cm total
06221139124069	Permthane X split Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 19 Cm total
06221139059309	Permthane X split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 50
06221139059293	Permthane X split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 35
06221139059286	Permthane X split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 31
06221139059279	Permthane X split Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 27
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