Catalog Number

-

Brand Name

SafeTrace Tx

Version/Model Number

3.x.x

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK150360

Product Code

MMH

Product Code Name

Blood Establishment Computer Software and Accessories

Public Device Record Key

71c3754c-36f5-40b2-993a-e6af6f73d63f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-