HVAD® Pump Implant Accessories

Basic Information

• Brand Name: HVAD® Pump Implant Accessories
• Primary DI: 00888707000147
• Version / Model: 1153
• Catalog Number: 1153
• Company Name: Heartware Inc.
• Labeler DUNS: 146054536
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-14
• Public Version: 3
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: 500c9fd0-207b-414a-9b59-2e1a0a1a3ede

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
16977	Artificial heart, temporary	A sterile prosthetic device implanted in the thorax or abdomen that typically consists of an implantable metallic and plastic mechanism that includes one or more pumps working as artificial ventricles to circulate blood, and an electrical or air driven external power unit that is connected to the pumps through transcutaneous electrical wires or pneumatic drive-lines entering the patient's chest. The power unit is attached to the patient and includes a battery and/or a pneumatic console. This device is used mostly as a bridge to heart transplantation.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888707000147	GS1