Catalog Number

H-7395

Brand Name

SUPPLEMENTAL VALVE LINE, ME.

Version/Model Number

H-7395

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DTM

Product Code Name

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Public Device Record Key

71acff4f-cd91-445f-b6da-9f294a6c1f14

Public Version Date

March 09, 2022

Public Version Number

3

DI Record Publish Date

October 09, 2015

Package DI Number

B066H73953

Quantity per Package

20

Contains DI Package

B066H73950

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE