Catalog Number

11401

Brand Name

TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE

Version/Model Number

11401

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

BK190333

Product Code

MMH

Product Code Name

Blood Establishment Computer Software And Accessories

Public Device Record Key

3fe38641-66bd-4f1a-8f4b-ef42428cc591

Public Version Date

August 17, 2022

Public Version Number

2

DI Record Publish Date

April 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-