Catalog Number

OPT32412U

Brand Name

OPTFlow

Version/Model Number

OPT32412U

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

K140131,K140131

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

cbd1fe90-a675-4cf0-9e64-949d72e7f7c9

Public Version Date

October 09, 2020

Public Version Number

5

DI Record Publish Date

March 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-