Catalog Number

182101

Brand Name

PFT KIT A, DISPOSABLE, QTY 100, 31 MM O.D.

Version/Model Number

PFT KIT A - 182101

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

30e5f555-afa2-4ac3-9688-5927a4889e68

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Package DI Number

00817081027341

Quantity per Package

100

Contains DI Package

00817081027334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-