Livit Blood Collection Kit

Organization name

Nightingale Health Oyj

SRN

FI-MF-000021253

Manufacturer status

Active

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

• CW008

  Sample return bag is considered a biohazard
• CW011

  Contains sharp objects
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW999

  Do not use if user has bleeding disorder
• CW999

  For in vitro diagnostic use only
• CW999

  Minor bruising may occur around the sample collection site
• CW135

  EUDAMED did not publish a description for this code.
• CW999

  For external use only

Primary placement in Finland; available across 26 countries total.

Trade name

Livit Blood Collection Kit

UDI-DI code

06429810164032

Basic UDI-DI

6429810164DBSKIT9M

Reference / catalog number

NGH-0302

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Livit Blood Collection Kit is intended for the collection, separation of plasma, storage, and transport of a whole blood sample from a fingerstick for in vitro diagnostics purposes. The blood sample can be self-collected by an adult lay user at home or can be collected by a healthcare professional. The device is for single use only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0501010201CAPILLARY BLOOD COLLECTION SYSTEMS

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