Sherlock 3CG+ TCS

Basic Information

• Brand Name: Sherlock 3CG+ TCS
• Primary DI: 00801741179747
• Version / Model: S3CG+ v 3.0.1
• Catalog Number: S3CG+ v 3.0.1
• Company Name: Bard Access Systems, Inc.
• Labeler DUNS: 044611812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-25
• Public Version: 1
• Public Version Date: 2019-02-25
• Public Version Status: New
• Public Device Record Key: 7bf1e711-ed6a-4848-ac32-4156ea5d8d8b

Device Description

Sherlock 3CG+ TCS CVAD Tip Confirmation System

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61667	Central venous catheter navigation system, electrocardiographic/magnetic	An assembly of devices intended to use electrocardiographic (ECG) and magnetic data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC)]. It includes a mains electricity (AC-powered) control unit [with internal rechargeable batteries] and visual display, ECG skin electrodes, lead(s) and cable(s), a magnetic sensor to be placed on the patient’s chest, and a remote control. The system is designed to be used with a dedicated catheter/stylet (not included) which functions as an intravascular ECG electrode and magnet whose position is detected by the sensor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741179747	GS1

Customer Contacts

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