Catalog Number

-

Brand Name

JOHN BUNN

Version/Model Number

JB0112-016

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

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

2b60c2ef-1392-4216-b571-62a29ba8fb20

Public Version Date

July 25, 2019

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

M368JB01120162

Quantity per Package

12

Contains DI Package

M368JB01120161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-