Catalog Number

JB02020

Brand Name

JOHN BUNN

Version/Model Number

JB02020

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

K063641,K063641

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

65427c57-d20a-415b-b75f-d2cc10da3027

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

May 05, 2020

Package DI Number

M368020202

Quantity per Package

136

Contains DI Package

M368JB020201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box