Catalog Number

181115

Brand Name

PFT Kit B, 30mm Kit with Blue Foam Nose Clip

Version/Model Number

PFT Kit B, 30mm - 181115

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

ee3a156f-105e-4aba-8148-ece0059cff8d

Public Version Date

June 28, 2021

Public Version Number

1

DI Record Publish Date

June 18, 2021

Package DI Number

00817081026962

Quantity per Package

100

Contains DI Package

00817081026955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-