Catalog Number

201-30105

Brand Name

EM-TEC ADULT FLOW PROBE FOR 2ND GEN CENTRIMAG PRIMARY CONSOLE

Version/Model Number

201-30105

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

-

Product Code

DWA

Product Code Name

Control, pump speed, cardiopulmonary bypass

Public Device Record Key

373ed78a-b8cc-4e13-b94c-237877c68629

Public Version Date

January 31, 2019

Public Version Number

5

DI Record Publish Date

September 20, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-