Catalog Number

-

Brand Name

MPS® Mini-Prime Delivery Set

Version/Model Number

7001101

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

Yes

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

K953838,K953838

Product Code

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Public Device Record Key

043efd1f-b4f2-4249-86ea-6091f0ed3276

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

October 06, 2015

Package DI Number

20634624701117

Quantity per Package

10

Contains DI Package

00634624701113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-