VasoPrep Vein Preparation Kit

Basic Information

• Brand Name: VasoPrep Vein Preparation Kit
• Primary DI: 00860002037813
• Version / Model: VAP-VSR-0002
• Company Name: VASOPREP SURGICAL, LLC
• Labeler DUNS: 078468395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-22
• Public Version: 1
• Public Version Date: 2019-08-30
• Public Version Status: New
• Public Device Record Key: f27786af-86d1-4613-8335-89e644917d2c

Device Description

VasoPrep Vein Preparation Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
GBX	Catheter, Irrigation	General, Plastic Surgery	878.4200	1

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	00860002037813	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131659	000