DLP®

Basic Information

• Brand Name: DLP®
• Primary DI: 20613994918530
• Version / Model: 65125
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• 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: 1648cb85-3711-464c-b83e-77510aad54ca

Device Description

SYRINGE 65125 PRESSURE 125MM 10PK 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
DTL	Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass	Cardiovascular	870.4290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44552	Vein irrigation/distention set	A collection of devices used for the distention and irrigation of veins (e.g., saphenous) for testing and clearance prior to removal of a section for use as a coronary or peripheral bypass graft. It is also used for vein distention to facilitate ligating side branches in the vein. It typically consists of a standard syringe (e.g., 60 ml), various stainless steel devices (pin, spring, rod), and plastic rings and balls that are used during the process. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20613994918530	GS1
Unit of Use	00613994918536	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K853586	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			125 mmHg