Catalog Number

384304

Brand Name

First Midcath™ S/L Midline Catheter Basic Kit

Version/Model Number

384304

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"

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

K972254,K972254

Product Code

FOZ

Product Code Name

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

Public Device Record Key

0e230249-c0c3-4186-9f85-38250eb66621

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20886333209785

Quantity per Package

5

Contains DI Package

00886333209781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box