Catalog Number

29-8993-050

Brand Name

Pulmoguard

Version/Model Number

II

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 27, 2020

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)

Yes

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,K934509

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

b4abb86e-080f-4779-8dd1-73ec6a96a847

Public Version Date

February 28, 2020

Public Version Number

4

DI Record Publish Date

July 25, 2016

Package DI Number

B279S298993200

Quantity per Package

50

Contains DI Package

B279S298993050

Package Discontinue Date

February 27, 2020

Package Status

Not in Commercial Distribution

Package Type

case