AccessGUDID - DEVICE: THRUPORT SYSTEMS ENDOVENT PULMONARY CATHETER KIT (00690103182866)

GUDID

Device Identifier (DI) Information

Brand Name: THRUPORT SYSTEMS ENDOVENT PULMONARY CATHETER KIT
Version or Model: EV
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EV
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103182866
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: ENDOVENT PULMONARY CATHETER KIT

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:	Yes
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 [?]
K981009	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
Special Storage Condition, Specify: STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 8.3 FR. (2.8 MM) X 25.6" (65 CM)

Device Record Status

Public Device Record Key: 40d9ff13-1ead-4edd-98ff-899f6fa8f406
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016