Catalog Number

189129

Brand Name

PFT Kit E, VBMax28E, w/ Foam Nose Clip

Version/Model Number

PFT Kit E, VBMax28E - 189129

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

3b767a50-e314-470f-b6d8-bd151f430e8b

Public Version Date

March 22, 2019

Public Version Number

1

DI Record Publish Date

March 14, 2019

Package DI Number

00817081022247

Quantity per Package

100

Contains DI Package

00817081022230

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-