CliniMACS Tubing Set LS 162-01

GUDID 04049934004841

CliniMACS® Tubing Set (LS) is a single-use, sterile, disposable tubing set with two proprietary cell separation columns used as part of the CliniMACS

Miltenyi Biotec GmbH

Magnetic cell separation system tubing set
Primary Device ID04049934004841
NIH Device Record Keyadf9097c-f311-4c33-be83-30dc956c0410
Commercial Distribution StatusIn Commercial Distribution
Brand NameCliniMACS Tubing Set LS
Version Model Number73205
Catalog Number162-01
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 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

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
GS104049934004841 [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 Steriletrue

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 Instrument2018-07-06 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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