EnSite™

Basic Information

• Brand Name: EnSite™
• Primary DI: 05415067024909
• Version / Model: H702490
• Catalog Number: H702490
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-02
• Public Version: 4
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 8ba8aadc-d9a5-4ce0-8fc8-1a606e8b3fd0

Device Description

Noise Reduction Transformer, 100V

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQK	COMPUTER, DIAGNOSTIC, PROGRAMMABLE	Cardiovascular	870.1425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16933	Constant-voltage transformer	A device designed to deliver a fixed, predetermined voltage that is one of a limited range of input voltage variations. The device receives a fluctuating input voltage and transforms this fluctuating voltage into a steady (constant) output helping to avoid such fluctuations which are present in the electrical system. These fluctuations may be known as spikes, and can be harmful to devices with sensitive electronics. This device may be inserted into new or existing electrical systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067024909	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141050	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Do not use if package is damaged.