HeartWare® Controller 1403US

GUDID 00888707000116

Heartware Inc.

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• Primary Device ID: 00888707000116
• NIH Device Record Key: fd476548-7f48-47e4-99ff-0edcd26befb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartWare® Controller
• Version Model Number: 1403US
• Catalog Number: 1403US
• 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: 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	00888707000116 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-08-14

On-Brand Devices [HeartWare® Controller]

• 00888707000475: 1403US
• 00888707000116: 1403US