CliniMACS Plus Instrument 151-01

GUDID 04049934004636

The CliniMACS® plus Instrument is a software-controlled instrument that processes the HPC, Apheresis as part of the CliniMACS CD34 Reagent System. The

Miltenyi Biotec GmbH

Magnetic cell separation system processing unit
Primary Device ID04049934004636
NIH Device Record Key95288b53-7e1a-4cb2-8324-cabdde1d654f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCliniMACS Plus Instrument
Version Model Number75101
Catalog Number151-01
Company DUNS327036034
Company NameMiltenyi Biotec GmbH
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-810-3135
EmailRegulatory_Affairs_USA@milteny
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_Affairs_USA@miltenyibiotec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104049934004636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVGMagnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-03-26

Devices Manufactured by Miltenyi Biotec GmbH

04049934004674 - CliniMACS PBS/EDTA Buffer 1L2019-05-31 CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System
04049934000270 - CryoMACS® Freezing Bag 502018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934000287 - CryoMACS® Freezing Bag 2502018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934000294 - CryoMACS® Freezing Bag 5002018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934000300 - CryoMACS® Freezing Bag 7502018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934000317 - CryoMACS® Freezing Bag 10002018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934004636 - CliniMACS Plus Instrument2018-07-06The CliniMACS® plus Instrument is a software-controlled instrument that processes the HPC, Apheresis as part of the CliniMACS CD34 Reagent System. The
04049934004636 - CliniMACS Plus Instrument2018-07-06 The CliniMACS® plus Instrument is a software-controlled instrument that processes the HPC, Apheresis as part of the CliniMACS C
04049934004672 - CliniMACS PBS/EDTA Buffer 1L2018-07-06 CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System

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