4F REGULAR COAXIAL DILATOR JT130400000

GUDID 50810988020687

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 ID: 50810988020687
• NIH Device Record Key: fc5e9510-ca0d-46e7-8881-e76e005352a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4F REGULAR COAXIAL DILATOR
• Version Model Number: JT130400000
• Catalog Number: JT130400000
• 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: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com
• Phone: 18663854047
• Email: customerservice@jetmedicalinc.com

Device Dimensions

• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810988020682 [Primary]
GS1	50810988020687 [Package]; Contains: 00810988020682; Package: [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: 2015-07-20

Devices Manufactured by JET MEDICAL, INC.

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• 50810988021226 - MEDCOMP GEN III POWER INJECTABLE PORT: 2019-12-05 8F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
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• 50810988021622 - N/A: 2019-11-29 6.6F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER