HeartWare® Controller DC Adapter 1440

GUDID 00888707002745

Heartware Inc.

Implantable ventricular circulatory assist system

• Primary Device ID: 00888707002745
• NIH Device Record Key: 2bab5b7c-a4d4-47e1-bf5d-33d71ee5ce02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartWare® Controller DC Adapter
• Version Model Number: 1440
• Catalog Number: 1440
• 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: 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	00888707002745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100047

FDA Product Code

• DSQ: Ventricular (Assisst) Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-27

On-Brand Devices [HeartWare® Controller DC Adapter]

• 00888707006842: 1440
• 00888707002745: 1440
• 00888707000260: 1440
• 00888707000109: 1435
• 00888707006880: 1440
• 00888707009935: 1440