Catalog Number

-

Brand Name

Buffalo Filter

Version/Model Number

BTLDXS01/BTLDXS04

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

-

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

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Public Device Record Key

dd89daba-80d5-4e13-9f0f-29c0f67860ba

Public Version Date

April 22, 2022

Public Version Number

5

DI Record Publish Date

January 13, 2017

Package DI Number

10815198012127

Quantity per Package

4

Contains DI Package

00815198012120

Package Discontinue Date

April 21, 2022

Package Status

Not in Commercial Distribution

Package Type

case