THORATEC® HEARTMATE II®, SEALED OUTFLOW GRAFT WITH BEND RELIEF

Basic Information

• Brand Name: THORATEC® HEARTMATE II®, SEALED OUTFLOW GRAFT WITH BEND RELIEF
• Primary DI: 00813024010807
• Version / Model: 103393
• Catalog Number: 103393
• 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: 3e80e981-6e35-4c83-ab18-88aebba26b70

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
61747	Implantable ventricular circulatory assist system outflow cannula, animal-derived	An implantable tube which includes animal-derived materials (e.g., synthetic polymer sealed with mammalian gelatin), intended to function as an outflow for an implantable ventricular circulatory assist system, to channel blood pumped from the left ventricle into the aorta via a surgically-created anastomosis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813024010807	GS1

Customer Contacts

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

Storage Conditions

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