GENIUS Blood and Marrow Concentration (BM/C) System G20030

GUDID M263G2003009

Disposable Unit

DSM BIOMEDICAL, INC.

Haematological concentrate system preparation kit, platelet concentration
Primary Device IDM263G2003009
NIH Device Record Key77cf0408-c970-49c6-9d95-1e96321adde0
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENIUS Blood and Marrow Concentration (BM/C) System
Version Model Number64050-04
Catalog NumberG20030
Company DUNS131107757
Company NameDSM BIOMEDICAL, INC.
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter
Total Volume30 Microliter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM263G2003009 [Primary]

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2016-10-31

On-Brand Devices [GENIUS Blood and Marrow Concentration (BM/C) System]

M263G20060060mL Disposable Kit
M263G2003009Disposable Unit
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