Catalog Number

-

Brand Name

BioFlo

Version/Model Number

AU17

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"

-

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

-

Product Code

FCN

Product Code Name

Urinary Drainage Collection Kit, For Indwelling Catheter

Public Device Record Key

9f65ac46-43c7-49ae-a764-5b567b759434

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 08, 2019

Package DI Number

B567AU171

Quantity per Package

20

Contains DI Package

B567AU170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box