1502200

Organization name

Berlin Heart GmbH

SRN

DE-MF-000006521

Manufacturer status

—

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

• CW010

  EUDAMED did not publish a description for this code.
• CW027

  EUDAMED did not publish a description for this code.
• CW017

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 28 countries total.

Trade name

not provided

UDI-DI code

04260090041840

Basic UDI-DI

4260090042540QK

Reference / catalog number

1502200

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

EXCOR Active driving unit ROW (REF 1502200) including the following components: 1502500 Battery, 1501300 Battery charging unit, 15017XX power cable* (*country specific XX = 00 (EU) / 01 (US) / 02 (DK) / 03 (GB) / 04 (CH) / 05 (AU) / 06 (JP) / 07 (ZA) / 08 (IL) / 09 (AR) / 10 (BR)), 1501200 power supply unit, 1502300 Manual Pump, 1505000 Flow sensor set 1: FS06-06-P, 1505010 Flow sensor set 2: FS09-09-P, 1505020 Flow sensor set 3: FS09-12-P, 1505030 Flow sensor set 5: FS12-12-P, 1505040 Flow sensor set 4: FS09-12-C, 1505050 Flow sensor set 6: FS12-12-C 1505100 Cable wrap incl. wrapping tool, 1501530 USB Stick, 1501540 USB cable, 1501550 Adapter for external alarm, 1550100 Stroller board, 1501400 Caddy, 1550110 Caddy quattro kit, 1501405 Accessory bag, 1501500 Panel PC, 1501510 Docking station, 1501520 Panel PC power supply unit,

Additional information URL

https://www.berlinheart.de/mediaroom/downloads/

Clinical sizes

No clinical sizes registered for this device.

• Z12050201EXTRA-CORPOREAL CIRCULATION SYSTEMS

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