BASHIR™ .035 Endovascular Catheter 8201

GUDID 00850005115076

Bashir™ .035 Endovascular Catheter 8Fr, 12.5cm basket

THROMBOLEX, INC.

Peripheral vascular intervention infusion catheter

• Primary Device ID: 00850005115076
• NIH Device Record Key: 953b37e1-f9a6-4703-8ca1-8e24d96b1239
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BASHIR™ .035 Endovascular Catheter
• Version Model Number: 8201
• Catalog Number: 8201
• 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: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com
• Phone: 2678983947
• Email: amy@thrombolex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005115076 [Primary]
GS1	10850005115073 [Package]; Package: Case [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231653

FDA Product Code

• KRA: Catheter, Continuous Flush

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-19
• Device Publish Date: 2023-12-11

Devices Manufactured by THROMBOLEX, INC.

• 00850005115076 - BASHIR™ .035 Endovascular Catheter: 2023-12-19Bashir™ .035 Endovascular Catheter 8Fr, 12.5cm basket
• 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