Catalog Number

Intravascular catheter 18Gx1.25"

Brand Name

MF SAFECATH

Version/Model Number

SS207

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

K192230,K192230,K192230

Product Code

FOZ

Product Code Name

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

Public Device Record Key

3180efd8-56de-4126-8eb4-fe0e8cd0eb48

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 10, 2020

Package DI Number

28800055100399

Quantity per Package

200

Contains DI Package

18800055100392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case