St. Jude Medical™

Basic Information

• Brand Name: St. Jude Medical™
• Primary DI: 05415067004772
• Version / Model: LT100
• Catalog Number: LT100
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-13
• Public Version: 3
• Public Version Date: 2023-10-06
• Public Version Status: Update
• Public Device Record Key: 5c8ba0fe-15c2-4a64-ae7c-2e7d87db2481

Device Description

Mechanical Heart Valve Leaflet Tester

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KDC	INSTRUMENT, SURGICAL, DISPOSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47469	Heart valve prosthesis tester, single-use	A sterile, pen-like device intended to be used to manually manipulate a heart valve prosthesis to perform an assessment of the valvular prosthesis (e.g., its ability to open and close) prior to implantation and/or when in situ. It typically has a handle made of plastic and a soft tip (e.g., made of rubber) to prevent damage of the valvular prosthesis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15415067004779	GS1		20	In Commercial Distribution
Primary	05415067004772	GS1

Customer Contacts

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