Catalog Number

189165

Brand Name

PFT Kit E, VBMax35E

Version/Model Number

PFT Kit E, VBMax35E - 189165

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

f8902a93-d4f7-45a7-a7e8-b2f4adb88847

Public Version Date

May 13, 2019

Public Version Number

1

DI Record Publish Date

May 03, 2019

Package DI Number

00817081022513

Quantity per Package

100

Contains DI Package

00817081022506

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-