Catalog Number

-

Brand Name

Guardian® II NC hemostasis valve

Version/Model Number

8216

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DTL

Product Code Name

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Public Device Record Key

31deeb3c-df6a-496a-8880-b84e8433924d

Public Version Date

March 05, 2020

Public Version Number

5

DI Record Publish Date

September 05, 2016

Package DI Number

M20682161

Quantity per Package

25

Contains DI Package

M20682160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box