Catalog Number

390-25

Brand Name

V-Cath

Version/Model Number

390-25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K983916,K983916

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

0b88ba0d-e146-4e07-808f-584a50a5588d

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

B339390255

Quantity per Package

10

Contains DI Package

B339390250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case