Catalog Number

MTS9650

Brand Name

MTS

Version/Model Number

MTS9650

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

Yes

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

-

FDA Premarket Submission

BK950026

Product Code

KSS

Product Code Name

SUPPLIES, BLOOD-BANK

Public Device Record Key

0b2f0ab8-d3d3-4bd3-af62-d52d5ccb1248

Public Version Date

December 21, 2018

Public Version Number

4

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-