CliniMACS Tubing Set LS

Primary DI
04049934004841
Brand
CliniMACS Tubing Set LS
Company
Miltenyi Biotec B.V. & Co. KG
Model
73205
Catalog number
162-01
Device description
"CliniMACS® Tubing Set (LS) is a single-use, sterile, disposable tubing set with two proprietary cell separation columns used 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
Sterile
true
Single use
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
04049934004841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049934004841040499340048414049934004841

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic cell separation system tubing setA sterile tubing set that is a component of a magnetic cell separation system intended to be used for the magnetic separation of target cell types or subpopulations from heterogeneous human cell preparations. It typically consists of flexible plastic tubes, connectors (e.g., spike, Luer-lock), connectors, bags (e.g. waste, target cells) and separation columns; it may also include filters, clamps, and centrifugation, cultivation, and heating/cooling chambers. The set provides a sterile interior fluid path. This is a single-use 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
Lot or batch
true
Expiration 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
04049934004636CliniMACS Plus Instrument75101151-012015-03-26
04049934004827CliniMACS CD34 Reagent70103171-012015-03-26
04049934004834CliniMACS Tubing Set TS73105161-012016-07-22
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
04049934004636CliniMACS Plus InstrumentMiltenyi Biotec B.V. & Co. KGOVG2015-03-26
04049934004827CliniMACS CD34 ReagentMiltenyi Biotec B.V. & Co. KGOVG2015-03-26