Catalog Number

-

Brand Name

Acrodose PL System

Version/Model Number

732-80

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"

Yes

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

BK060044,BK060044

Product Code

KSR

Product Code Name

CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Public Device Record Key

fc9b4254-c108-4d32-8d4c-17a30d9ba08a

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

December 15, 2016

Package DI Number

30887691307882

Quantity per Package

40

Contains DI Package

10887691307888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-