HVAD® Pump Outflow Graft 1125

GUDID 00888707007641

Heartware Inc.

Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system

• Primary Device ID: 00888707007641
• NIH Device Record Key: e4eae4d9-e573-4d99-ad90-92abd0fd5438
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HVAD® Pump Outflow Graft
• Version Model Number: 1125
• Catalog Number: 1125
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888707007641 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-20
• Device Publish Date: 2020-11-10

On-Brand Devices [HVAD® Pump Outflow Graft]

• 00888707000222: 1125
• 00888707007634: MCS1725OG
• 00888707007641: 1125