Catalog Number

JB0112-111

Brand Name

John Bunn

Version/Model Number

JB0112-111

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161586,K161586

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

6806f135-3388-489f-b567-5420ac1c1326

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 25, 2020

Package DI Number

M368JB01121112

Quantity per Package

4

Contains DI Package

M368JB01121111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-