Catalog Number

-

Brand Name

Monaghan™ Z STAT®

Version/Model Number

aVHC, Mouthpiece, cs/10

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

K052332,K052332

Product Code

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Public Device Record Key

f0a3bf39-1da4-4d35-9d13-faaaae545c9b

Public Version Date

September 09, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

50604351797159

Quantity per Package

10

Contains DI Package

00604351797154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-