AccessGUDID - DEVICE: Edwards Lifesciences Vent Catheter (00690103147469)

GUDID

Device Identifier (DI) Information

Brand Name: Edwards Lifesciences Vent Catheter
Version or Model: EM012
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EM012
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103147469
Issuing Agency: GS1
Commercial Distribution End Date: November 14, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: Vent Catheter

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?
46363	Chamber-decompression cardiac catheter	A thick plastic tube designed to decompress a heart chamber during a surgical procedure. It is typically used to decompress the left heart during cardiopulmonary bypass surgery, especially the left ventricle during aortic cross-clamping. It may include a pressure monitoring line to continuously measure the pressure of a chamber. 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 [?]
K113411	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: 12 Fr. (4.0 mm) x 35 cm (14")

Device Record Status

Public Device Record Key: 6b5fd30a-d913-4aa4-9986-56d512891b4c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016