Catalog Number

183114

Brand Name

PFT Kit B, 33mm OD Kit

Version/Model Number

PFT Kit B, 33mm OD Kit - 183114

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

63516b86-b5de-4a5c-b913-1074f956b078

Public Version Date

October 08, 2021

Public Version Number

1

DI Record Publish Date

September 30, 2021

Package DI Number

00817081027075

Quantity per Package

100

Contains DI Package

00817081027068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-