Catalog Number

-

Brand Name

NA

Version/Model Number

HY10Z01R8

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

Yes

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

-

FDA Premarket Submission

K171979

Product Code

DWF

Product Code Name

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Public Device Record Key

2a7aeecb-055e-4069-91bb-48b4d7fd71b2

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-