Bashir™ N-X Endovascular Catheter

GUDID 00850005115014

THROMBOLEX, INC.

Peripheral vascular infusion catheter

• Primary Device ID: 00850005115014
• NIH Device Record Key: d6b78d8c-1a45-47d7-9f68-3e473ea4c8d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bashir™ N-X Endovascular Catheter
• Version Model Number: 7200
• Company DUNS: 080580521
• Company Name: THROMBOLEX, 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: false
• 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: 2678983974
• Email: amy@thrombolex.com
• Phone: 2678983974
• Email: amy@thrombolex.com
• Phone: 2678983974
• Email: amy@thrombolex.com
• Phone: 2678983974
• Email: amy@thrombolex.com
• Phone: 2678983974
• Email: amy@thrombolex.com
• Phone: 2678983974
• Email: amy@thrombolex.com
• Phone: 2678983974
• Email: amy@thrombolex.com
• Phone: 2678983974
• Email: amy@thrombolex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005115014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183290

FDA Product Code

• KRA: Catheter, Continuous Flush

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: 2020-02-11
• Device Publish Date: 2019-04-10

Devices Manufactured by THROMBOLEX, INC.

• 00850005115076 - BASHIR™ .035 Endovascular Catheter: 2023-12-19 Bashir™ .035 Endovascular Catheter 8Fr, 12.5cm basket
• 10850005115080 - BASHIR™ S-B .035 Endovascular Catheter: 2023-12-19 Bashir™ .035 S-B Endovascular Catheter 8Fr, 10.0cm basket
• 00850005115021 - Bashir™ S-B Endovascular Catheter 7Fr, 10.0cm basket: 2020-02-25 Bashir™ S-B Endovascular Catheter 7Fr, 10.0cm basket
• 00850005115038 - Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion: 2020-02-25 Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion
• 00850005115045 - Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 20.0cm Infusion: 2020-02-25 Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 20.0cm Infusion
• 00850005115052 - Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 30.0cm Infusion: 2020-02-25 Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 30.0cm Infusion
• 00850005115069 - Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 40.0cm Infusion: 2020-02-25 Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 40.0cm Infusion
• 00850005115007 - Bashir™ Endovascular Catheter: 2020-02-11