Catalog Number

-

Brand Name

InspiraChamber Valved Holding Chamber

Version/Model Number

1001-50

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

K130598,K130598

Product Code

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Public Device Record Key

385f82ba-6c25-4576-aefb-bba479ba88d2

Public Version Date

July 24, 2019

Public Version Number

1

DI Record Publish Date

July 16, 2019

Package DI Number

10852367007065

Quantity per Package

50

Contains DI Package

00852367007068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case