Catalog Number

-

Brand Name

JOHN BUNN

Version/Model Number

5710

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

-

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

2e0cb853-bc5d-495f-8e1e-1b3961398076

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

M36857102

Quantity per Package

6

Contains DI Package

M36857101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-