THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL SEWING RING

Basic Information

• Brand Name: THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL SEWING RING
• Primary DI: 00813024010234
• Version / Model: 1065
• Catalog Number: 1065
• Company Name: Thoratec Corporation
• Labeler DUNS: 070156955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 7
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 0eee704f-d637-446a-bdd5-829b478a2c56

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
61750	Implantable ventricular circulatory assist system inflow cannula, synthetic polymer	An implantable tube 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. It is made of a synthetic polymer(s) and does not include biologically-derived materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813024010234	GS1
Unit of Use	00813024012375	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius