Tennafix™

Basic Information

• Brand Name: Tennafix™
• Primary DI: 05414734400749
• Version / Model: 1205
• Catalog Number: 1205
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-08
• Public Version: 4
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 4e7021e3-4bc2-4127-adb1-f039a0170af7

Device Description

Adhesive Pads

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61069	Cable/lead/sensor non-conductive skin-adherent patch	An adhesive, non-conductive patch/pad intended to secure a cable/lead/sensor used during a medical procedure [e.g., cardiopulmonary resuscitation (CPR) sensor, ECG lead, phototherapy unit cable] to the skin of a patient. It has no electrical or conducting components or properties and is made of synthetic polymer materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15414734400746	GS1		100	Not in Commercial Distribution	2016-11-11
Primary	05414734400749	GS1
Package	35414734400740	GS1		5	In Commercial Distribution
Package	25414734400743	GS1		20	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P010032	019

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 150 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 150 KiloPascal