AccessGUDID - DEVICE: Z-MED II™ (04046964335976)

GUDID

Device Identifier (DI) Information

Brand Name: Z-MED II™
Version or Model: 611675
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 611675
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964335976
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: SO079 SPECIAL ZMED II 30X5X100

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":	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Cardiac valvuloplasty catheter	A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Cardiac valvuloplasty catheter

A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
LIT	Catheter, angioplasty, peripheral, transluminal
DQY	CATHETER, PERCUTANEOUS
OZT	Balloon aortic valvuloplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003052	000
K122012	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: ROOM TEMP AWAY FROM SUNLIGHT

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e53d55c5-1adf-4db3-99e5-262288c96087
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: August 09, 2016