HVAD Pump Implant Kit 1103

GUDID 00888707003261

Heartware Inc.

Implantable ventricular circulatory assist system

• Primary Device ID: 00888707003261
• NIH Device Record Key: 5d6f94b9-7db8-4d7d-9e46-6137271feb53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HVAD Pump Implant Kit
• Version Model Number: A00118US
• Catalog Number: 1103
• 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: true
• 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	00888707003261 [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: 1
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-10-22

On-Brand Devices [HVAD Pump Implant Kit]

• 00888707003261: A00118US
• 00888707000062: 1103