Catalog Number

91443A

Brand Name

Flexport

Version/Model Number

91443A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 16, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K903702

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

c028c263-3fe1-4c4f-8f5a-93de5afe225d

Public Version Date

August 16, 2019

Public Version Number

7

DI Record Publish Date

November 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-