Catalog Number

-

Brand Name

JOHN BUNN

Version/Model Number

JB0112-070

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K052811,K052811

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

e85e5b47-ab26-4b19-9949-4baeedbfdb05

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

M368JB01120702

Quantity per Package

12

Contains DI Package

M368JB01120701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-