5F REGULAR COAXIAL DILATOR JT130500000

GUDID 50810988020694

JET MEDICAL, INC.

Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable
Primary Device ID50810988020694
NIH Device Record Key1e22281f-aada-4e26-8e35-8974940d8752
Commercial Distribution StatusIn Commercial Distribution
Brand Name5F REGULAR COAXIAL DILATOR
Version Model NumberJT130500000
Catalog NumberJT130500000
Company DUNS079506014
Company NameJET MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com
Phone18663854047
Emailcustomerservice@jetmedicalinc.com

Device Dimensions

Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100810988020699 [Primary]
GS150810988020694 [Package]
Contains: 00810988020699
Package: [10 Units]
In Commercial Distribution

FDA Product Code

MPBCatheter, Hemodialysis, Non-Implanted

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-07-20

Devices Manufactured by JET MEDICAL, INC.

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50810988021608 - N/A2019-12-05 6.6F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
50810988021196 - MEDCOMP GEN III POWER INJECTABLE PORT2019-12-05 6.6F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
50810988021202 - MEDCOMP GEN III POWER INJECTABLE PORT2019-12-05 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
50810988021219 - MEDCOMP GEN III POWER INJECTABLE PORT2019-12-05 6.6F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
50810988021226 - MEDCOMP GEN III POWER INJECTABLE PORT2019-12-05 8F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
50810988021615 - N/A2019-11-29 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
50810988021622 - N/A2019-11-29 6.6F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER

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