HVAD® Pump Surgical Tools - Extended Length 1328

GUDID 00888707000451

Heartware Inc.

Implantable ventricular circulatory assist system

• Primary Device ID: 00888707000451
• NIH Device Record Key: 4d7ddc21-2aa1-49cb-9400-ba176d5b3a9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HVAD® Pump Surgical Tools - Extended Length
• Version Model Number: 1328
• Catalog Number: 1328
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888707000451 [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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-11

Devices Manufactured by Heartware Inc.

• 00763000629717 - HeartWare® Battery: 2023-05-29
• 00888707007641 - HVAD® Pump Outflow Graft: 2023-04-20
• 00888707007658 - HVAD® Controller: 2023-04-20
• 00888707008020 - Alarm Adapter: 2023-04-20
• 00888707008037 - Patient Pack: 2023-04-20
• 00888707008044 - USB Flash Drive: 2023-04-20
• 00888707008051 - Data Cable: 2023-04-20
• 00888707008204 - HVAD® Pump Surgical Tools: 2023-04-20