Catalog Number

-

Brand Name

Flexichamber

Version/Model Number

Anti-Static Valved Collapsible Holding Chamber

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2020

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)

-

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

adb5ed3e-8175-48a2-a5a0-7cddf7a0451e

Public Version Date

June 30, 2020

Public Version Number

2

DI Record Publish Date

June 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-