AccessGUDID - DEVICE: Edwards Lifesciences Porous Vent Plug (00690103042115)

GUDID

Device Identifier (DI) Information

Brand Name: Edwards Lifesciences Porous Vent Plug
Version or Model: VP038
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VP038
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103042115
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: Porous Vent Plug

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K861322	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 3798b57e-32a3-493a-9be4-07bd41926bf7
Public Version Date: February 19, 2021
Public Version Number: 5
DI Record Publish Date: August 31, 2016