Catalog Number

-

Brand Name

KIDS

Version/Model Number

D131 INFANT ART. FILTER PH + 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

K072308,K072308

Product Code

DTM

Product Code Name

Filter, blood, cardiopulmonary bypass, arterial line

Public Device Record Key

0482c6f5-d2b6-4d70-bf94-cd60cd82dd21

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 03, 2015

Package DI Number

38033178109315

Quantity per Package

8

Contains DI Package

08033178109314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX