Catalog Number

-

Brand Name

JOHN BUNN

Version/Model Number

GF61400

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

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

K052811,K052811

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

03b472fa-25bc-4310-a2a5-fbac9e6fa46f

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

M368GF614002

Quantity per Package

50

Contains DI Package

M368GF614001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-