THORATEC® HEARTMATE II®, LVAS IMPLANT KIT

Basic Information

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT
• Primary DI: 00813024011996
• Version / Model: 107801
• Catalog Number: 107801
• Company Name: Thoratec Corporation
• Labeler DUNS: 070156955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 5
• Public Version Date: 2019-02-28
• Public Version Status: Update
• Public Device Record Key: b5955d7a-ac53-4a1d-8637-ca6bc1a7d6a2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
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	00813024011996	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 93 Percent (%) Relative Humidity