Catalog Number

-

Brand Name

FDK

Version/Model Number

FT-E688

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

Yes

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

e4484ea4-aa21-45cf-a2ae-194880619bfb

Public Version Date

December 06, 2021

Public Version Number

2

DI Record Publish Date

November 24, 2021

Package DI Number

10859020006151

Quantity per Package

50

Contains DI Package

00859020006154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack