Catalog Number

7287

Brand Name

Pro Comfort Inhaler Space Chamber w/ CHILD mask

Version/Model Number

2.4.7

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DYN

Product Code Name

Mouthpiece, Saliva Ejector

Public Device Record Key

5e477eb7-3d24-46a0-bdd9-f37f355afc1e

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 19, 2018

Package DI Number

10850632007284

Quantity per Package

50

Contains DI Package

00850632007287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case