Catalog Number

-

Brand Name

Sarns™ Centrifugal Pump without X-Coating™

Version/Model Number

164275

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

K112229,K112229

Product Code

KFM

Product Code Name

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Public Device Record Key

382df0bc-e69a-458c-b74e-2098e0a013c9

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2014

Package DI Number

50699753002338

Quantity per Package

8

Contains DI Package

00699753002333

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-