Catalog Number

-

Brand Name

Inspirachamber with SootherMask (medium) and InspiraMask (medium)

Version/Model Number

IPX1026

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"

Yes

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

-

Product Code

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Public Device Record Key

3b184525-1d51-4214-8edc-f20e30e77a28

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

August 30, 2019

Package DI Number

30327437026016

Quantity per Package

10

Contains DI Package

00327437026015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper