HVAD® Pump Surgical Tools – Extended Length MCS1728ST

GUDID 00888707005395

Heartware Inc.

Implantable ventricular circulatory assist system

• Primary Device ID: 00888707005395
• NIH Device Record Key: 1841bf4d-32e5-45f9-baaa-9923bcc76c27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HVAD® Pump Surgical Tools – Extended Length
• Version Model Number: MCS1728ST
• Catalog Number: MCS1728ST
• Company DUNS: 146054536
• Company Name: Heartware 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888707005395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100047

FDA Product Code

• DSQ: Ventricular (Assist) Bypass

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: 2020-12-22
• Device Publish Date: 2020-12-14

On-Brand Devices [HVAD® Pump Surgical Tools – Extended Length]

• 00888707005395: MCS1728ST
• 00888707008723: 1328