Venos Occlusion Balloon Catheter

Basic Information

• Brand Name: Venos Occlusion Balloon Catheter
• Primary DI: 00836559006916
• Version / Model: V0510010
• Catalog Number: V0510010
• Company Name: Oscor Inc.
• Labeler DUNS: 101835833
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: daea1892-b87e-4364-b90d-1ae332c9cf24
• Distribution End Date: 2017-10-27

Device Description

Occlusion Balloon Catheter, 5F

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYG	CATHETER, FLOW DIRECTED	Cardiovascular	870.1240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42417	Cardiac sizing catheter	A sterile flexible tube with an inflatable balloon at the distal end designed for use in a patient with a cardiovascular defect wherein accurate measurement of the defect is important to select the appropriately sized occlusion device. It is typically designed to pass over a guidewire and it will have radiopaque marker bands along it distal end to assist in placement using fluoroscopy. It is made of plastic materials and metal [e, g, platinum (Pt) for the bands] and is available in a variety of designs and sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00836559006916	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081052	000

Device Sizes

Type	Value	Unit	Text
Length	100	Centimeter
Device Size Text, specify			Balloon Diameter 10 mm
Outer Diameter	1.7	Millimeter
Device Size Text, specify			Required Syringe Size 0.75 cc

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius