Catalog Number

DBFS21

Brand Name

BIO-FLEX®TESIO®

Version/Model Number

DBFS21

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 12, 2021

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

MSD

Product Code Name

Catheter, hemodialysis, implanted

Public Device Record Key

950cb5de-cb4d-43f9-83dc-8e1faa0cb8e3

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2019

Package DI Number

50884908145934

Quantity per Package

10

Contains DI Package

00884908145939

Package Discontinue Date

July 12, 2021

Package Status

Not in Commercial Distribution

Package Type

box