BioCUE® Concentration System 800-0611A

GUDID 00880304681484

Biomet Biologics, LLC

Haematological concentrate system
Primary Device ID00880304681484
NIH Device Record Keya2036825-1f6b-4a64-b954-18044054ffc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioCUE® Concentration System
Version Model Number800-0611A
Catalog Number800-0611A
Company DUNS802003074
Company NameBiomet Biologics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304681484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-24
Device Publish Date2018-11-14

Devices Manufactured by Biomet Biologics, LLC

00880304640962 - Bilateral BMA Kit2021-11-08
00880304460645 - GPS® III2020-02-05
00880304460652 - GPS® III2020-02-05
00880304681477 - BioCUE® Mini Concentration System2020-01-24
00880304681484 - BioCUE® Concentration System2020-01-24
00880304681484 - BioCUE® Concentration System2020-01-24
00880304680333 - PERFUSE DECOMPRESSION INSTRUMENTATION2019-08-09
00880304400085 - Biomet®2019-06-19
00880304400092 - Plasmax® Counterbalance2019-06-19

Trademark Results [BioCUE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOCUE
BIOCUE
77832108 4012981 Live/Registered
BIOMET MANUFACTURING, LLC
2009-09-22

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