HeartWare® Monitor 1521US

GUDID 00888707009256

Heartware Inc.

Implantable ventricular circulatory assist system

• Primary Device ID: 00888707009256
• NIH Device Record Key: 19f52f72-fedc-4c43-b75e-f0ac16cce9e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartWare® Monitor
• Version Model Number: 1521US
• Catalog Number: 1521US
• 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: 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	00888707009256 [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: 2022-08-23
• Device Publish Date: 2022-08-15

On-Brand Devices [HeartWare® Monitor]

• 00888707001632: 1520US
• 00888707000468: 1521US
• 00888707000123: 1520US
• 00888707009256: 1521US