Catalog Number

2184.005

Brand Name

EPICUTANEO-CAVA CATHETER

Version/Model Number

2184.005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

738ce02a-7858-4881-9b94-83885c800aaa

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 27, 2015

Package DI Number

33660812039575

Quantity per Package

10

Contains DI Package

03660812039574

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-