CliniMACS Tubing Set LS

FDA UDIEUDAMED

Class Unclassified (US FDA UDI)

Ref 162-01 / 200-073-204Ref 161-01 / 200-073-104

by Miltenyi Biotec B.V. & Co. KG

Identity

Trade Name: CliniMACS Tubing Set LS EUDAMEDFDA UDI
CliniMACS Tubing Set EUDAMED
Generic Name: Magnetic cell separation system tubing set FDA UDI
Device Name: CliniMACS Depletion Tubing Set EUDAMED
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. FDA UDI
Model / Reference: 162-01 / 200-073-204 EUDAMED
161-01 / 200-073-104 EUDAMED
73205 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 162-01 FDA UDI
Primary DI / UDI-DI: 04049934000164 EUDAMED
04049934000157 EUDAMED
04049934004841 FDA UDI
Basic UDI-DI: 4049934B000015L EUDAMED
FDA Product Code: OVG FDA UDI
EMDN Code: A0399 TUBULAR DEVICES - OTHER EUDAMED
GMDN Term: Magnetic cell separation system tubing set FDA UDI

Classification

Device Class: Class IIb EUDAMED
Unclassified FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Magnetic cell separation system tubing set

CliniMACS Tubing Set LS by Miltenyi Biotec B.V. & Co. KG — Class Unclassified — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Magnetic cell separation system tubing set.

CliniMACS Tubing Set TS — Miltenyi Biotec B.V. & Co. KG · Unclassified

Cleared under the same submission

BH110018 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class Unclassified	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class Unclassified	Pending data

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Manufacturer

Manufacturer: Miltenyi Biotec B.V. & Co. KG

Sources (3)

FDA UDI adf9097c-f311-4c33-be83-30dc956c0410 36 fields · synced Aug 1, 2026
EUDAMED d1c1e6f8-575a-44d4-8302-c1e7a8796cb4 61 fields · synced Jul 11, 2026
EUDAMED 28a38fe9-0fc9-45fe-9cec-76784848123d 61 fields · synced Jul 28, 2026