Catalog Number

PSFTS05

Brand Name

Buffalo Filter

Version/Model Number

PSFTS05

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2022

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"

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

GAZ

Product Code Name

Tubing, Noninvasive

Public Device Record Key

0af05947-9d31-47e4-96b6-89eb44e1e46f

Public Version Date

April 22, 2022

Public Version Number

4

DI Record Publish Date

January 06, 2017

Package DI Number

10851136002331

Quantity per Package

5

Contains DI Package

00851136002334

Package Discontinue Date

April 21, 2022

Package Status

Not in Commercial Distribution

Package Type

case