Acent-2

Organization name

Global Medikit Limited

SRN

IN-MF-000013635

Manufacturer status

Active

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

• CW009

  EUDAMED did not publish a description for this code.
• CW001

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

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 11 countries total.

Trade name

Acent-2

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.

08903545076504

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.

8903545GMLCVC003GZ

Reference / catalog number

4815302G

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

Central venous catheters are polyurethane, radiopaque single or multiple lumen catheters. The sizes of catheters are from 3 French through 12 French and lengths 80 mm (8 cm) through 30 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation or junction) hub, where it branches into dedicated extension lines. The extension line hubs are labeled to provide positive identification of the lumen size and location. The catheter body has depth markings, measured in mm (for 80 mm catheter length) and cm (for rest of the catheter length) from the catheter tips. The extension line marked “distal” is used for device placement using a guide wire and then to infuse fluids. The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient. Central venous catheters are inserted into a large vein and threaded into the central venous system. To reduce the chance of complications, the central venous catheter tip should be placed in the superior vena cava above its junction with the right atrium with the distal catheter parallel to the vessel wall.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 30 MU10
• 7 Fr
• Distal-62 ml/min, proximal-16 ml/min
• 14G/18G
• 2.33 MU50

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

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

• C01020202CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

• G70 113499 0006Issued
  Technical documentationNotified body: 0123Expiry: Jun 22, 2028