Amecath dual lumen catheter

GUDID 06221139058944

Permthane Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 31 Cm total length 36 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	06221139058944
NIH Device Record Key	bcb7609e-0b7d-4c29-a334-4bca39ca19e2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Amecath dual lumen catheter
Version Model Number	PDLC-1431-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	14 French
Length	31 Centimeter
Catheter Gauge	14 French
Length	31 Centimeter
Catheter Gauge	14 French
Length	31 Centimeter
Catheter Gauge	14 French
Length	31 Centimeter
Catheter Gauge	14 French
Length	31 Centimeter
Catheter Gauge	14 French
Length	31 Centimeter
Catheter Gauge	14 French
Length	31 Centimeter
Catheter Gauge	14 French
Length	31 Centimeter
Catheter Gauge	14 French
Length	31 Centimeter
Catheter Gauge	14 French
Length	31 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06221139058944 [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]

06221139123857	Permthane Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 35 Cm tot
06221139123840	Permthane Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 31 Cm tot
06221139123833	Permthane Long term dual lumen Pre-curved catheter kit size 15.5 Fr tip to cuff length 27 Cm tot
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
06221139123802	Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 35 Cm total length 4
06221139123796	Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 31 Cm total length 3
06221139123789	Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 27 Cm total length 3
06221139123772	Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 23 Cm total length 2
06221139123765	Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 19 Cm total length 2
06221139059798	Permthane Twin Long term dual lumen catheter kit size 14 Fr tip to cuff length 27 Cm total leng
06221139058968	Permthane Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 50 Cm total
06221139058951	Permthane Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 35 Cm total
06221139058944	Permthane Long term dual lumen Pre-curved catheter kit size 14 Fr tip to cuff length 31 Cm total
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