Acrodose PLus System

GUDID 30887691310684

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

HAEMONETICS CORPORATION

Blood/tissue storage/culture container
Primary Device ID30887691310684
NIH Device Record Key72d9c825-d3ae-4bf9-a560-86d8fde499a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcrodose PLus System
Version Model Number732-82
Company DUNS057827420
Company NameHAEMONETICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110887691310680 [Primary]
GS130887691310684 [Package]
Contains: 10887691310680
Package: [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-15

On-Brand Devices [Acrodose PLus System]

30887691310691Platelet Pool and Store Set with In-line Leukocyte Redcution Filter
30887691310684Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter and eBDS
30887691308193Pool and Store Set for Leukocyte-Reduced Platelets

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