Catalog Number

OPT12612U

Brand Name

OPTFlow

Version/Model Number

OPT12612U

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)

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

55e7f837-5138-44a6-aff2-00b3c97e580f

Public Version Date

October 08, 2020

Public Version Number

3

DI Record Publish Date

January 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-