Catalog Number

M842611PB

Brand Name

N/A

Version/Model Number

M842611PB

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

Yes

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

K870027,K870027

Product Code

CCQ

Product Code Name

NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Public Device Record Key

2bfd4d7e-3113-4330-80cd-b63722008de8

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 16, 2016

Package DI Number

10607411302104

Quantity per Package

50

Contains DI Package

00607411302107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-