Direxion™ HI-FLO™ Transend™-18 System

GUDID 08714729839835

Pre-Loaded Torqueable Microcatheter

BOSTON SCIENTIFIC CORPORATION

Vascular microcatheter

• Primary Device ID: 08714729839835
• NIH Device Record Key: 22277d20-9568-4796-bb5b-713941b5c891
• Commercial Distribution Discontinuation: 2022-10-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Direxion™ HI-FLO™ Transend™-18 System
• Version Model Number: M001195930
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729839835 [Primary]

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: 4
• Public Version Date: 2025-01-23
• Device Publish Date: 2016-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729839835 - Direxion™ HI-FLO™ Transend™-18 System: 2025-01-23Pre-Loaded Torqueable Microcatheter
• 08714729839835 - Direxion™ HI-FLO™ Transend™-18 System: 2025-01-23 Pre-Loaded Torqueable Microcatheter
• 08714729269915 - Electrophysiology Cable: 2025-01-15 Sterile Cable
• 08714729877868 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877875 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877882 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877899 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877905 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877912 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter