VENA TECH

Basic Information

• Brand Name: VENA TECH
• Primary DI: 04027478130752
• Version / Model: 5010028
• Catalog Number: 5010028
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC
• Labeler DUNS: 784259751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-17
• Public Version: 11
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: c60c93c2-b64d-4b20-b596-24b1e8740e33

Device Description

VenaTech® Convertible™

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTK	FILTER, INTRAVASCULAR, CARDIOVASCULAR	Cardiovascular	870.3375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44865	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).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04027478130752	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K152765	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12.90	French
Device Size Text, specify			Diameter (mm) : 28.000 MM
Device Size Text, specify			Length of catheter : 56.000 CM

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY
• Type: Special Storage Condition, Specify
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid extreme temperature
• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temp
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight