AccessGUDID - DEVICE: Venos Occlusion Balloon Catheter (00836559007098)

GUDID

Device Identifier (DI) Information

Brand Name: Venos Occlusion Balloon Catheter
Version or Model: V068015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: V068015
Company Name: Oscor Inc.

Primary DI Number: 00836559007098
Issuing Agency: GS1
Commercial Distribution End Date: October 27, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 101835833 *Terms of Use

Device Description: Occlusion Balloon Catheter, 6F

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYG	CATHETER, FLOW DIRECTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081052	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Required Syringe Size 2.0 cc
Length: 80 Centimeter
Device Size Text, specify: Balloon Diameter 15 mm
Outer Diameter: 2 Millimeter

Device Record Status

Public Device Record Key: 12187f1d-aa95-41c8-8e8d-95cf6c1897b0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 30, 2017