Heartware® Monitor

Basic Information

• Brand Name: Heartware® Monitor
• Primary DI: 00888707000468
• Version / Model: 1521US
• Catalog Number: 1521US
• Company Name: Heartware Inc.
• Labeler DUNS: 146054536
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 3
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: abc1104d-be71-4ba4-8387-723e7a1a255e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSQ	Ventricular (Assist) Bypass	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47533	Implantable ventricular circulatory assist system	A portable assembly of devices intended to provide mechanical assistance to a heart ventricle(s), typically by pumping blood from the left ventricle to the aorta through an extra-cardiac circuit. It includes an implantable pump(s), connecting cannula/graft(s), a percutaneous lead, and external components (e.g., battery pack, controller). It is typically intended to be used as a bridge to heart transplantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888707000468	GS1

Premarket Submissions

Submission Number	Supplement Number
P100047	000