Catalog Number

S00009-1-IL

Brand Name

Percussionaire

Version/Model Number

F00012-HT2-IL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 14, 2021

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,K905236

Product Code

NHJ

Product Code Name

Device, Positive Pressure Breathing, Intermittent

Public Device Record Key

e6d1eab1-97c2-4cd6-b556-058508480328

Public Version Date

July 15, 2021

Public Version Number

5

DI Record Publish Date

October 21, 2015

Package DI Number

10849436000362

Quantity per Package

1

Contains DI Package

00849436000365

Package Discontinue Date

July 14, 2021

Package Status

Not in Commercial Distribution

Package Type

Case