Catalog Number

-

Brand Name

JOHN BUNN

Version/Model Number

JB02008

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

DQA

Product Code Name

Oximeter

Public Device Record Key

ff6847cf-dc9d-49b8-b2f0-bf2e385011a2

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

M368JB020082

Quantity per Package

250

Contains DI Package

M368JB020081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-