Catalog Number

-

Brand Name

MICRO

Version/Model Number

D735 27µ NEW BORN ART.FILTER+PURGE LINE

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

K033987,K033987

Product Code

DTM

Product Code Name

Filter, blood, cardiopulmonary bypass, arterial line

Public Device Record Key

050b0090-778c-4522-b5b8-0377f8e109a9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 03, 2015

Package DI Number

38033178100886

Quantity per Package

6

Contains DI Package

08033178100885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX