Catalog Number

-

Brand Name

Innotech

Version/Model Number

YM201

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)

-

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

c03673b6-f045-4c98-ad43-63f62f5cfcab

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

March 16, 2021

Package DI Number

16947468500158

Quantity per Package

1

Contains DI Package

06947468500151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

1pcs/box