MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETER

GUDID 00810988020934

15.5F X 40CM JET FLOW LT CATHETER (CUFF 35CM FROM TIP)

JET MEDICAL, INC.

Double-lumen haemodialysis catheter, implantable
Primary Device ID00810988020934
NIH Device Record Key397659be-f97c-4717-a4c4-eebd7e411357
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETER
Version Model NumberJT011554001
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 Datetrue
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 Identifiers

Device Issuing AgencyDevice ID
GS100810988020934 [Primary]
GS150810988020939 [Package]
Package: BOX [5 Units]
In Commercial Distribution

FDA Product Code

MSDCatheter, Hemodialysis, 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 Date2017-05-09

Devices Manufactured by JET MEDICAL, INC.

50810988021509 - MICRO-STICK SET2020-02-03 5F STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE, 4CM NEEDLE
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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