SJM™

Basic Information

• Brand Name: SJM™
• Primary DI: 05415067009449
• Version / Model: 406427
• Catalog Number: 406427
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 66bb19b5-1261-40fa-9423-7330a1ae1b25

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
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47766	Haemostasis valve obturator	A sterile device designed to seal the sheath of a haemostasis valve to maintain sheath patency (i.e., to prevent blood from coagulating in the sheath and blocking access through the haemostasis valve). It is typically a long, thin, rod-like device made of plastic with a rounded distal tip and a cap at the proximal end; it is available in a variety of sizes (e.g., 4-13 French and 15-26 cm long). The proximal cap has a locking mechanism (e.g., a Luer-lock or snap lock) to hold it securely in place to prevent blood loss from the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15415067009446	GS1		10	In Commercial Distribution
Primary	05415067009449	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K884494	000

Device Sizes

Type	Value	Unit	Text
Length	15	Centimeter
Catheter Gauge	12	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dark, dry place.