EnSite™

Basic Information

• Brand Name: EnSite™
• Primary DI: 05414734210218
• Version / Model: System
• Catalog Number: H421021
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-10
• Public Version: 2
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: be5c632a-8850-48b6-9ce0-30cc7e7f0928

Device Description

RecordConnect

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
64392	Electrical-only medical device connection adaptor, reusable	A device intended to allow electrical connection of incompatible plugs/sockets on related medical devices (e.g., generator and controller) and/or cables. This device will typically be used when the system components are from different manufacturers or using different technologies, and the original connectors are not compatible; it has no additional non-electrical conduction or processing functionality. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734210218	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130594	000
K182644	000
K201181	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -25 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 55 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry.