SJM™

Basic Information

• Brand Name: SJM™
• Primary DI: 05414734502375
• Version / Model: FL-1056
• Catalog Number: FL-1056
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-25
• Public Version: 4
• Public Version Date: 2019-02-04
• Public Version Status: Update
• Public Device Record Key: cc31cc11-2fbf-4a6a-be0d-5ed654ffa826

Device Description

FLUSHING TOOL

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
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60902	Pacing lead implantation adaptor	A small, sterile device intended to be connected to the proximal end of a compatible cardiac pacing lead containing a lumen for over-guidewire implantation, to enable flushing of the lumen (typically with heparinized saline) and aid insertion of a guidewire during implantation. The distal end of the device is intended to connect to the pacing lead; the proximal end is intended to act as both a Luer connector, for attachment of a syringe, and a wire guide for guidewire insertion; it is not intended to be implanted. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734502375	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 23 – 122 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -5 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -5 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 23 – 122 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged.