Catalog Number

S00055

Brand Name

Percussionaire

Version/Model Number

Travel Air

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

27251ef7-02c0-425b-982c-93020df6f17e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 13, 2017

Package DI Number

10849436000249

Quantity per Package

1

Contains DI Package

00849436000242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box