Catalog Number

4385005

Brand Name

UMBILI-CATH

Version/Model Number

Triple-Lumen Polyurethane

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

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

K940952,K940952

Product Code

FOS

Product Code Name

Catheter, Umbilical Artery

Public Device Record Key

eeadd694-9fa5-4804-8619-f94c1dd49da2

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

H67143850051

Quantity per Package

10

Contains DI Package

H67143850050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box