Catalog Number

S00003-C-EU1

Brand Name

Percussionaire

Version/Model Number

F00002-C

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

K905236,K905236

Product Code

NHJ

Product Code Name

Device, Positive Pressure Breathing, Intermittent

Public Device Record Key

f2911781-a027-478c-972f-c6371ead82f3

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 20, 2018

Package DI Number

10849436000546

Quantity per Package

1

Contains DI Package

00849436000549

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE