NA

Basic Information

• Brand Name: NA
• Primary DI: 05415067042811
• Version / Model: 406500
• Catalog Number: 406500
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-16
• Public Version: 1
• Public Version Date: 2022-02-24
• Public Version Status: New
• Public Device Record Key: e39fecac-de87-4f56-88b8-7748aed9c831

Device Description

Repositioning Sleeve

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: No
• 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
DQR	CANNULA, CATHETER	Cardiovascular	870.1300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65312	Cardiovascular catheter sheath	A sterile, noninvasive, flexible sleeve intended to be used during cardiovascular catheterization (e.g., femoral, pulmonary) to cover and protect the exposed proximal end of a cardiovascular catheter to prevent contamination (extending the sterile field of the external catheter) and/or to contain a backflow of blood (e.g., during catheter introduction, repositioning or removal). It is typically transparent and includes appropriate connectors for distal attachment to the catheter introducer, and proximal attachment to the extracorporeal portion of the catheter. Neither the catheter nor introduction/procedural devices are included (i.e., not a set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067042811	GS1
Previous	05414734026505	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K884478	000

Device Sizes

Type	Value	Unit	Text
Length	30.0000	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry and dark area