Catalog Number

S00026-1H

Brand Name

Percussionaire

Version/Model Number

F00029-1

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

-

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

K905234,K905234

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

d507ceb4-7053-4bb2-8258-8e5b8e9d5d25

Public Version Date

September 30, 2020

Public Version Number

4

DI Record Publish Date

October 30, 2015

Package DI Number

10849436000423

Quantity per Package

1

Contains DI Package

00849436000426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case