Catalog Number

-

Brand Name

Welby

Version/Model Number

53497

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

DQA

Product Code Name

Oximeter

Public Device Record Key

979adef2-7f9a-4164-b107-340d78706932

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

August 19, 2020

Package DI Number

10041498239494

Quantity per Package

4

Contains DI Package

04099100186598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton