Explant Kit 1750

GUDID 00888707008785

Heartware Inc.

Implantable ventricular circulatory assist system

• Primary Device ID: 00888707008785
• NIH Device Record Key: e7984d82-9ff8-42f3-b3ee-f6ac990e9cf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Explant Kit
• Version Model Number: 1750
• Catalog Number: 1750
• 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: 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	00888707008785 [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: false

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 [Explant Kit]

• 00888707000215: 1750
• 00888707008785: 1750