12F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)

GUDID 50810988020984

14F X 24CM JET FLOW ST KIT

JET MEDICAL, INC.

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 Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable
Primary Device ID50810988020984
NIH Device Record Key8540f111-0e88-48fb-b764-8aa0aa9c7637
Commercial Distribution StatusIn Commercial Distribution
Brand Name12F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)
Version Model NumberJT031402401
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

Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com
Phone+1(866)385-4047
Emailcustomerservice@jetmedicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810988020989 [Primary]
GS150810988020984 [Package]
Contains: 00810988020989
Package: BOX [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 Date2017-06-20

On-Brand Devices [12F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)]

5081098802098414F X 24CM JET FLOW ST KIT
5081098802096014F X 15CM JET FLOW ST KIT
5081098802095314F X 12CM JET FLOW ST KIT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.