Catalog Number

29-7943-080

Brand Name

Pulmoguard

Version/Model Number

II

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 08, 2019

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K934509,K934509

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

df50aa15-8431-4481-a8f8-546bf4fc0764

Public Version Date

June 21, 2022

Public Version Number

5

DI Record Publish Date

July 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-