Edwards Lifesciences Porous Vent Plug

Basic Information

• Brand Name: Edwards Lifesciences Porous Vent Plug
• Primary DI: 00690103042115
• Version / Model: VP038
• Catalog Number: VP038
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 5
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 3798b57e-32a3-493a-9be4-07bd41926bf7

Device Description

Porous Vent Plug

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: No
• 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
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31667	Catheter orifice occluder	A plug-like device intended to be inserted into a catheter (e.g., Foley catheter), or a catheter-like invasive device, to prevent flow through one or more orifice(s) in the catheter; it may also be referred to as a catheter spigot or catheter tip occluder. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103042115	GS1
Package	50690103042110	GS1	Shipper	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K861322	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.952 cm (0.375") x 3.5 cm (1.25")