EKOS™ 600-40500H-AH

GUDID 00191506013738

Console

BOSTON SCIENTIFIC CORPORATION

Ultrasound thrombolysis system control unit

• Primary Device ID: 00191506013738
• NIH Device Record Key: 989e0457-0151-4a30-93f6-1abf72f46c1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EKOS™
• Version Model Number: 600-40500H-AH
• Catalog Number: 600-40500H-AH
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506013738 [Primary]

FDA Product Code

• QEY: Mechanical thrombolysis catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-18
• Device Publish Date: 2023-05-10

On-Brand Devices [EKOS™]

• 00850016840172: 600-40500D
• 00850016840158: Console
• 00850016840134: Console
• 00191506013738: Console
• 00191506013721: Console