CliniMACS Plus Instrument

Primary DI
04049934004636
Brand
CliniMACS Plus Instrument
Company
Miltenyi Biotec B.V. & Co. KG
Model
75101
Catalog number
151-01
Device description
"The CliniMACS® plus Instrument is a software-controlled instrument that processes the HPC, Apheresis as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on ""magnetically-activated cell sorting"" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag."
Published
2015-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVGMagnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)Unknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BH1100180

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BH1100180

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049934004636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049934004636040499340046364049934004636

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic cell separation system processing unitA mains electricity (AC-powered) device that is a component of a magnetic cell separation system designed to magnetically separate specific cell types or subpopulations from heterogeneous human cell preparations. It is a programmable device typically consisting of pumping/agitating mechanisms, a magnet, valves, bag hangers and a user display screen. It functions in combination with a magnetizing reagent, a buffered washing solution and a tubing set to separate the target cell population by retention in a magnetic field. The cells are typically used in regenerative medicine (e.g., cardiovascular, haematogenic) or disease treatment (e.g., oncology). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-810-3135Regulatory_Affairs_USA@milteny
800-810-3135Regulatory_Affairs_USA@miltenyibiotec.com

Regulatory Flags#

DUNS number
342920388
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049934004674CliniMACS PBS/EDTA Buffer 1L70026700-252016-07-22
04049934000270CryoMACS® Freezing Bag 5074400200-074-4002017-12-18
04049934000287CryoMACS® Freezing Bag 25074401200-074-4012016-07-22
04049934000294CryoMACS® Freezing Bag 50074402200-074-4022016-07-22
04049934000300CryoMACS® Freezing Bag 75074403200-074-4032016-07-22
04049934000317CryoMACS® Freezing Bag 100074404200-074-4042016-07-22
04049934004827CliniMACS CD34 Reagent70103171-012015-03-26
04049934004834CliniMACS Tubing Set TS73105161-012016-07-22
04049934004841CliniMACS Tubing Set LS73205162-012015-03-26
040499341337257-AAD Staining Solution170-081-0882021-03-26
04049934133732CD45RA-FITC170-081-0862021-03-26
04049934133749Anti-TCRg/d-PE-Vio770170-081-0852021-03-26
04049934133756CD4-VioGreen (Clone REA623)170-081-0842021-03-26
04049934133763CD197-VioBlue170-081-0832021-03-26
04049934133770CD62L-PE-Vio770170-081-0822021-03-26
04049934133787CD62L-VioGreen170-081-0812021-03-26
04049934133794CD45RA-VioBlue170-081-0802021-03-26
04049934133800CD34-VioBlue170-081-0792021-03-26
04049934133817CD45-VioGreen (Clone REA747)170-081-0782021-03-26
04049934133824CD45-VioBlue (Clone REA747)170-081-0772021-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049934004674CliniMACS PBS/EDTA Buffer 1LMiltenyi Biotec B.V. & Co. KGOVG2016-07-22
04049934004672CliniMACS PBS/EDTA Buffer 1LMiltenyi Biotec GmbHOVG2016-07-22
04049934004834CliniMACS Tubing Set TSMiltenyi Biotec B.V. & Co. KGOVG2016-07-22
04049934004827CliniMACS CD34 ReagentMiltenyi Biotec B.V. & Co. KGOVG2015-03-26
04049934004841CliniMACS Tubing Set LSMiltenyi Biotec B.V. & Co. KGOVG2015-03-26