DEVICE: VENA TECH (04027478130752)
Device Identifier (DI) Information
VENA TECH
5010028
In Commercial Distribution
5010028
B BRAUN INTERVENTIONAL SYSTEMS, INC
5010028
In Commercial Distribution
5010028
B BRAUN INTERVENTIONAL SYSTEMS, INC
VenaTech® Convertible™
Device Characteristics
MR Conditional | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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).
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DTK | FILTER, INTRAVASCULAR, CARDIOVASCULAR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152765 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: KEEP DRY |
Special Storage Condition, Specify: |
Special Storage Condition, Specify: Avoid extreme temperature |
Special Storage Condition, Specify: Store at room temp |
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type 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 |
Device Record Status
c60c93c2-b64d-4b20-b596-24b1e8740e33
September 07, 2023
11
March 17, 2016
September 07, 2023
11
March 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com