Catalog Number

-

Brand Name

InspiraChamber Valved Holding Chamber

Version/Model Number

IC-VHC-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

9940f535-2db6-45f7-9b4c-6771685cf981

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 18, 2017

Package DI Number

10852367007003

Quantity per Package

50

Contains DI Package

00852367007006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-