Catalog Number

-

Brand Name

The MetaNeb®System

Version/Model Number

C20000AE

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"

-

For Single-Use

Yes

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

NHJ

Product Code Name

DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Public Device Record Key

97a1859e-0cff-4bc9-9bbf-82cde709d96a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 31, 2017

Package DI Number

10887761997148

Quantity per Package

5

Contains DI Package

00887761997141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-