Organization name

Cerus Corporation

SRN

US-MF-000000765

Manufacturer status

Active

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

• Consult instructions for use

  Refer to Instructions for Use

Primary placement in Austria; available across 31 countries total.

Trade name

INTERCEPT Processing Set for Platelets Large Volume

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.

18717953197044

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.

872058919007PLT2L

Reference / catalog number

INT22, INT2203B

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.

GS1

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 III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The INTERCEPT Processing Set for Platelets is used with an INTERCEPT Illuminator to inactivate a broad spectrum of viruses, bacteria, and parasites as well as contaminating donor leukocytes in platelet components. This process for treatment of platelet components is intended to reduce the risk of transfusion-associated transmission of viruses, bacteria, and parasites, and the risk of adverse effects due to transfusion of contaminating donor leukocytes.

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.

• 18717953197044× 1 unitBase unit
  • 28717953197041× 24 units

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

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

• B010199BLOOD COLLECTION BAGS AND KITS - OTHER

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.