Organization name

Vivostat A/S

SRN

DK-MF-000019521

Manufacturer status

Active

12 warnings recorded — scroll inside the panel to see all entries.

• Patient-derived Vivostat® PRF is for autologous use only – check patient details to ensure patient donor and recipient are the same.

  OTHER

• Spray is achieved using pressurised air. Caution should be used where there is a risk of air embolism. We recommend using the spray mode “JET NO AIR” in neurosurgery.

  OTHER

• Not for intravascular use.

  OTHER

• Do not use past indicated date
• Do not use if package is damaged
• Do not re-use
• Do not resterilize
• Contraindication: Known hypersensitivity to batroxobin and tranexamic acid.

  OTHER

• Consult instructions for use
• Caution

  Warning: after use the device may contain biohazardous materials, such as body fluids. Perform cleaning according to universal blood handling precautions

• Contains biological material of animal origin
• It is recommended to prepare Vivostat® PRF from patient derived whole blood only.

  OTHER

Primary placement in Denmark; available across 29 countries total.

Trade name

Vivostat® PRF Set – Concorde

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.

05704808000310

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.

B-05704808000310

Reference / catalog number

VS 410

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://vivostat.com/user-guides/

Clinical sizes

No clinical sizes registered for this device.

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

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

• A030499ADMINISTRATION KITS - OTHER
• B0599TOPICAL USE BLOOD COMPONENTS PREPARATION DEVICES - OTHER

• Class III medical devices in EUDAMED

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