MDU5 Plus™ H749MDU5PLUSFE0

GUDID 00191506052454

Motordrive Unit

BOSTON SCIENTIFIC CORPORATION

Cardiovascular ultrasound imaging system

• Primary Device ID: 00191506052454
• NIH Device Record Key: 66a28ddb-7b83-4903-9e37-34b2a7a3da51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDU5 Plus™
• Version Model Number: H749MDU5PLUSFE0
• Catalog Number: H749MDU5PLUSFE0
• 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: true
• 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	00191506052454 [Primary]

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

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: 2025-12-17
• Device Publish Date: 2025-12-09

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 00191506052454 - MDU5 Plus™: 2025-12-17Motordrive Unit
• 00191506052454 - MDU5 Plus™: 2025-12-17 Motordrive Unit
• 08714729146841 - The Magnet™: 2025-12-12 Exchange Device
• 08714729008828 - The Magnet™: 2025-12-12 Exchange Device
• 08714729808497 - Flextome® Cutting Balloon®: 2025-12-12 Microsurgical Dilatation Device
• 08714729808503 - Flextome® Cutting Balloon®: 2025-12-12 Microsurgical Dilatation Device
• 08714729808510 - Flextome® Cutting Balloon®: 2025-12-12 Microsurgical Dilatation Device
• 08714729808527 - Flextome® Cutting Balloon®: 2025-12-12 Microsurgical Dilatation Device
• 08714729808534 - Flextome® Cutting Balloon®: 2025-12-12 Microsurgical Dilatation Device