Catalog Number

-

Brand Name

Inspirachamber with InspiraMask (Large)

Version/Model Number

IC-IML-0

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

1f75d8ef-96b9-4932-a441-ceff33f2322d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 18, 2017

Package DI Number

10852367007010

Quantity per Package

10

Contains DI Package

00852367007013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-