Acrodose PLus System - Platelet Pool and Store Set with In-Line - HAEMONETICS CORPORATION

Duns Number:057827420

Device Description: Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter and eBDS

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More Product Details

Catalog Number

-

Brand Name

Acrodose PLus System

Version/Model Number

732-82

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

BK080003,BK080003

Product Code Details

Product Code

KSR

Product Code Name

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

Device Record Status

Public Device Record Key

72d9c825-d3ae-4bf9-a560-86d8fde499a1

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

December 15, 2016

Additional Identifiers

Package DI Number

30887691310684

Quantity per Package

40

Contains DI Package

10887691310680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HAEMONETICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 158
U Unclassified 2