Organization name

GenesisBPS, LLC

SRN

US-MF-000046970

Manufacturer status

Active

Primary placement in Netherlands; available across 32 countries total.

Trade name

Genesis Tube Stripper

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.

00866305000288

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.

08663050002HS-002HT

Reference / catalog number

4A-HS-002

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Tube Stripper is a “plier-like” tool used to strip/expel undiluted residual blood from the PVC tubing segment back into the blood component bag. When used in blood/blood component processing applications, the Tube Stripper only facilitates manual mixing with anticoagulant and red cells. The Tube Stripper has no intended medical purpose and is not intended for in vitro use in blood banking. The Tube Stripper operates on the principle of using two rolling wheels to squeeze fluid forward. The operator manually places the PVC tubing segment between the two roller wheels, grips the clamp body, and slides the Tube Stripper forward along the PVC tubing segment. As the segment is compressed between the two roller wheels, the fluid within the PVC tubing segment flows forward until it completely drains into the blood component bag. The Tube Stripper only facilitates the manual mixing of residual blood in the PVC tube segment with the anticoagulant and red cells inside the blood component bag.

Additional information URL

https://www.genesisbps.com/

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.

• B99HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER

• Class I medical devices in EUDAMED

This device is not currently linked to any other device.

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