Catalog Number

S00018-1

Brand Name

Percussionaire

Version/Model Number

F00008-1

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

K905235,K905235

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

6009e9ea-6a89-4fdf-9c74-9a0c111d3569

Public Version Date

September 02, 2020

Public Version Number

4

DI Record Publish Date

October 21, 2015

Package DI Number

10849436000041

Quantity per Package

1

Contains DI Package

00849436000044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case