THORATEC® HEARTMATE II®, SEALED INFLOW CONDUIT

Basic Information

• Brand Name: THORATEC® HEARTMATE II®, SEALED INFLOW CONDUIT
• Primary DI: 00813024010791
• Version / Model: 104142
• Catalog Number: 104142
• 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: 6
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 145af3db-c5d7-47ef-b8cf-9ade443c34fc

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
61749	Implantable ventricular circulatory assist system inflow cannula, animal-derived	An implantable tube which includes animal-derived materials (e.g., synthetic polymer sealed with mammalian gelatin), intended to function as an inflow for an implantable ventricular circulatory assist system, to channel blood from the left ventricle to the implanted system pump.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813024010791	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 35 Degrees Celsius