Organization name

Arteriocyte Medical Systems, Inc

SRN

US-MF-000011472

Manufacturer status

Active

+M896MDK3050

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

1 warning recorded — scroll inside the panel to see all entries.

• Contraindication: The use of the Arteriocyte Medical Systems, Inc. Magellan® Platelet Separation System is contraindicated for a hemodynamically unstable or hypercoagulable patient.

  OTHER

Primary placement in Spain; available across 32 countries total.

Trade name

Basic Platelet Separator Kit

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

+M896MDK3050

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

++M896MDK3057U

Reference / catalog number

MDK305

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

HIBCC

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The Magellan® Autologous Platelet Separator System (including associated Disposable Kits) are intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood or a small sample of a mixture of blood and bone marrow. The plasma and concentrated platelets produced can be used for diagnostic tests. Additionally, platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic as deemed necessary by the clinical use requirements. The Magellan® Autologous Platelet Separator Disposable Kits consists of sterile fluid pathway single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator instrument.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• +M896MDK3050× 1 unitBase unit
  • +M896MDK3051× 5 units

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• B019003BLOOD COMPONENTS ALIQUOTATION KITS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.