Catalog Number

910047

Brand Name

Cascade

Version/Model Number

910047

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2020

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

BK020051

Product Code

KSS

Product Code Name

Supplies, Blood-Bank

Public Device Record Key

c18f1cbd-4f90-49a8-a850-656d490b4db0

Public Version Date

September 29, 2020

Public Version Number

6

DI Record Publish Date

December 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-