Printer

Basic Information

• Brand Name: Printer
• Primary DI: 05415067018076
• Version / Model: H701807
• Catalog Number: H701807
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-09
• Public Version: 2
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 6c5278bf-5025-4ed4-adbe-b77fa3fddd26

Device Description

Printer

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: Yes
• Has Lot/Batch Number: No
• 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
JOQ	Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)	Cardiovascular	870.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38449	Laser printer	An electrically-powered printing device designed to use laser and an electro-photographic (using toner) method to print on paper; it is not intended to produce labels.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067018076	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092913	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry