Catalog Number

4178005

Brand Name

UMBILI-CATH

Version/Model Number

Single-Lumen Silicone

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

K940953,K940953

Product Code

FOS

Product Code Name

Catheter, Umbilical Artery

Public Device Record Key

faef505d-01f6-4f38-980e-15870538992b

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

H67141780051

Quantity per Package

10

Contains DI Package

H67141780050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box