Catalog Number

-

Brand Name

BioFlo

Version/Model Number

60M140565

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

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

cc8a5ae4-a64b-4b7d-8b7c-abeb7bf35350

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 17, 2015

Package DI Number

M00160M1405651

Quantity per Package

4

Contains DI Package

M00160M1405650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX