Catalog Number

-

Brand Name

HAEMONETICS ACP 215 SYSTEM

Version/Model Number

00225-00

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

BK060008,BK060008

Product Code

KSW

Product Code Name

SYSTEM, PROCESSING FOR FROZEN BLOOD

Public Device Record Key

dc8e48a2-b2b0-4021-aef6-0b8129a84f75

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 07, 2017

Package DI Number

30812747015008

Quantity per Package

50

Contains DI Package

10812747015004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-