Catalog Number

S00033-1

Brand Name

Percussionaire

Version/Model Number

F00038-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 04, 2022

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

-

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

K905235,K905235

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

5f437791-0be0-45aa-b755-94fe4e4816c9

Public Version Date

March 11, 2022

Public Version Number

4

DI Record Publish Date

October 21, 2015

Package DI Number

10849436000058

Quantity per Package

1

Contains DI Package

00849436000051

Package Discontinue Date

March 04, 2022

Package Status

Not in Commercial Distribution

Package Type

Case