Catalog Number

-

Brand Name

LILLIPUT

Version/Model Number

D902 PH.I.S.I.O.

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

-

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

648303cb-e323-4dcf-a167-4792bfbc71ef

Public Version Date

January 22, 2020

Public Version Number

3

DI Record Publish Date

June 23, 2015

Package DI Number

38033178100398

Quantity per Package

6

Contains DI Package

08033178100397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX