Catalog Number

-

Brand Name

SoftBank

Version/Model Number

25.1.3.0

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

BK100045

Product Code

MMH

Product Code Name

Software, Blood Bank, Stand Alone Products

Public Device Record Key

652df3c8-beea-43b0-a9d8-50371b4af1c5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-