VXSY-10-1

Organization name

OPED GmbH

SRN

DE-MF-000008286

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.
• CW259

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

  optionally contain NiMH battery packs.Don’t try to open the device! The batteries may only be replaced by authorized specialists
• CW999

  Absolute contraindications: • In patients where increased backflow to the heart could have a negative effect, e.g patients with decompensated heart failure or severe, non-adjustable hypertension • Acute thrombophlebitis • Acute deep leg vein thrombosis • Full-blown compartment syndrome (with necrosis of the musculature) Relative contraindications for the following cases - after weighing-up of the benefits and risks by the treating physician: • Pulmonary embolism • Severe infection of the treated extremity
• CW999

  Do not use the VADOplex System as a toy.
• CW999

  If the power cord or device case is obviously damaged, do not connect it to an AC power source as electrical shock could occur. Never pull on the cable to disconnect the device from the mains, always pull on the plug. Always unplug the appliance BEFORE making any localised changes and/or moving the hospital bed.
• CW999

  Do not drop the device, impact, or immerse in water. Don’t try to open the device! Do not use the VADOplex System outside or on wet surfaces. Do not store or operate the VADOplex System in direct sunlight, as overheating could occur.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04046618014219

Basic UDI-DI

4046618Z120607VX8H

Reference / catalog number

VXSY-10-1

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z120607PNEUMATIC COMPRESSION EQUIPMENT

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