Catalog Number

181128

Brand Name

PFT Kit A, Disposable, 28MM OD Filter

Version/Model Number

PFT Kit A, 28MM OD Filter - 181128

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K000654,K000654

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

6ffac4ff-7327-485b-972f-4f2a4d032252

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 03, 2020

Package DI Number

00817081023701

Quantity per Package

100

Contains DI Package

00817081023695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-