Catalog Number

S00010-4

Brand Name

Percussionaire

Version/Model Number

F00012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2020

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

K905236

Product Code

NHJ

Product Code Name

Device, Positive Pressure Breathing, Intermittent

Public Device Record Key

d8e65e1a-e602-42cb-9bf5-7e0bc9ba41be

Public Version Date

March 12, 2020

Public Version Number

4

DI Record Publish Date

September 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-