Catalog Number

-

Brand Name

SYNERGY

Version/Model Number

STD PTS PHISIO

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

K032040,K032040

Product Code

KFM

Product Code Name

PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Public Device Record Key

0c987069-22f1-4453-ad6c-8cb669784ae8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 23, 2014

Package DI Number

38033178241220

Quantity per Package

1

Contains DI Package

08033178241229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

TRAY