HVAD® Pump Outflow Graft 1125

GUDID 00888707000222

Heartware Inc.

Artificial heart, temporary

• Primary Device ID: 00888707000222
• NIH Device Record Key: bdf8bdba-87a7-4593-9a9c-ad75757c11c8
• 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: true
• Serial Number: false
• 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	00888707000222 [Primary]

FDA Product Code

• DSQ: Ventricular (Assisst) 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: 2018-03-29
• Device Publish Date: 2014-08-14

On-Brand Devices [HVAD® Pump Outflow Graft]

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