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

GUDID 00810988020972

14F X 20CM 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 ID: 00810988020972
• NIH Device Record Key: 245b869a-d719-4b15-891c-3ab6e2ee6fd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12 F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)
• Version Model Number: JT031402001
• Company DUNS: 079506014
• Company Name: JET MEDICAL, INC.
• 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: false
• 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: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com
• Phone: +1(866)385-4047
• Email: customerservice@jetmedicalinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810988020972 [Primary]
GS1	50810988020977 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• MPB: Catheter, Hemodialysis, Non-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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-20

Devices Manufactured by JET MEDICAL, INC.

• 50810988021509 - MICRO-STICK SET: 2020-02-03 5F STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE, 4CM NEEDLE
• 50810988021608 - N/A: 2019-12-05 6.6F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
• 50810988021196 - MEDCOMP GEN III POWER INJECTABLE PORT: 2019-12-05 6.6F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
• 50810988021202 - MEDCOMP GEN III POWER INJECTABLE PORT: 2019-12-05 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
• 50810988021219 - MEDCOMP GEN III POWER INJECTABLE PORT: 2019-12-05 6.6F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
• 50810988021226 - MEDCOMP GEN III POWER INJECTABLE PORT: 2019-12-05 8F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
• 50810988021615 - N/A: 2019-11-29 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
• 50810988021622 - N/A: 2019-11-29 6.6F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER