HVAD® Controller A00154US

GUDID 00888707006859

Heartware Inc.

Implantable ventricular circulatory assist system

• Primary Device ID: 00888707006859
• NIH Device Record Key: c667d24d-eec3-4cbe-9766-7e0f7d97645a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HVAD® Controller
• Version Model Number: 1403US
• Catalog Number: A00154US
• Company DUNS: 146054536
• Company Name: Heartware Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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	00888707006859 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-15
• Device Publish Date: 2019-10-07

On-Brand Devices [HVAD® Controller]

• 00888707006859: 1403US
• 00888707000420: 1420
• 00888707007658: 1420