Catalog Number

BDMOXMTRBLK

Brand Name

BodyMed

Version/Model Number

BDMOXMTRBLK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Public Device Record Key

f786f018-e911-405b-84af-32eb9a3b5dc4

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

November 05, 2019

Package DI Number

20815991022634

Quantity per Package

100

Contains DI Package

00815991022630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton