Catalog Number

-

Brand Name

VANGUARD

Version/Model Number

D928S BLOOD DELIVERY SET 8:1

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

K934847,K934847

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Public Device Record Key

d611fd0b-6f0d-49b9-889a-840255f6d68f

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

July 10, 2015

Package DI Number

38033178250628

Quantity per Package

4

Contains DI Package

08033178250627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX