DLP®

Basic Information

• Brand Name: DLP®
• Primary DI: 20613994578956
• Version / Model: 31204
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-06-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1dc30cdc-6dd7-463b-b5ca-4d02ac1e6d47

Device Description

CANNULA 31204 ARTERIOTOMY 4MM 6.3 20 17L

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34914	Coronary artery perfusion catheter	A sterile, flexible tube designed to perfuse the coronary arteries with shunted blood (e.g., from a femoral artery) to prevent ischemia typically during off-pump coronary artery bypass grafting or during minimally-invasive cardiac surgical procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20613994578956	GS1
Unit of Use	00613994578952	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K994171	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	4.0	Millimeter
Length	16.0	Centimeter