Catalog Number

-

Brand Name

BioFlo

Version/Model Number

PKM61055311S

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

K121990,K121990

Product Code

LJS

Product Code Name

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

Public Device Record Key

1059b482-a470-4587-bcbb-ab163122bc00

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

November 12, 2018

Package DI Number

H965PKM61055311S1

Quantity per Package

3

Contains DI Package

H965PKM61055311S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX