Catalog Number

-

Brand Name

ByFloProducts

Version/Model Number

BFP50D1

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

34437e38-0cad-48c9-926b-fe49fecdf78d

Public Version Date

May 24, 2022

Public Version Number

1

DI Record Publish Date

May 16, 2022

Package DI Number

10628693098042

Quantity per Package

200

Contains DI Package

00628693098045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box