Catalog Number

902-100

Brand Name

Flexichamber

Version/Model Number

Anti-Static Valved Collapsible Holding Chamber

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 07, 2018

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)

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

838dfae8-91fe-4bf2-86cd-9a97a4337e1f

Public Version Date

November 08, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

00313551000017

Quantity per Package

44

Contains DI Package

00313551000000

Package Discontinue Date

November 07, 2018

Package Status

Not in Commercial Distribution

Package Type

Carton Box