Catalog Number

S00018-1FR

Brand Name

Percussionaire

Version/Model Number

F00008-1FR

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

8faf7c86-e2df-4869-b6e5-5957443c2713

Public Version Date

March 11, 2022

Public Version Number

2

DI Record Publish Date

January 22, 2021

Package DI Number

10849436000195

Quantity per Package

1

Contains DI Package

00849436000198

Package Discontinue Date

March 04, 2022

Package Status

Not in Commercial Distribution

Package Type

Case