THORATEC® VAD, RVAD PNEUMATIC LEAD 5FT

Basic Information

• Brand Name: THORATEC® VAD, RVAD PNEUMATIC LEAD 5FT
• Primary DI: 00813024012610
• Version / Model: 20010-0000-109
• Catalog Number: 20010-0000-109
• 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: 8
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 9b27af88-e10c-45c1-983b-e420f6745670

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
46721	Disposable vacuum tubing	A sterile length of flexible tube intended to be used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of malleable synthetic polymer material(s) (e.g., plastic, silicone) and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required (e.g., for an autologous blood transfusion system). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813024012610	GS1

Customer Contacts

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

Storage Conditions

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