AccessGUDID - DEVICE: VENA TECH (04027478130752)

GUDID

Device Identifier (DI) Information

Brand Name: VENA TECH
Version or Model: 5010028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5010028
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04027478130752
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: VENATECH CONVERTIBLE FILTER/J-F/USA

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
Vena cava filter, permanent	A permanently implanted vascular device intended to be percutaneously placed in the inferior vena cava (IVC) to prevent pulmonary embolism (PE). The device achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding, wire designs (e.g., conical, basket).

GMDN Preferred Term Name

GMDN Definition

Vena cava filter, permanent

A permanently implanted vascular device intended to be percutaneously placed in the inferior vena cava (IVC) to prevent pulmonary embolism (PE). The device achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding, wire designs (e.g., conical, basket).

FDA Product Code

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Product Code	Product Code Name
DTK	FILTER, INTRAVASCULAR, CARDIOVASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152765	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

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Size Type Text
Catheter Gauge: 12.90 French
Device Size Text, specify: Diameter (mm) : 28.000 MM

Device Record Status

Public Device Record Key: c60c93c2-b64d-4b20-b596-24b1e8740e33
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: March 17, 2016