VivaFoam™

Organization name

Sunmedic AB

SRN

SE-MF-000012997

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Contraindications: VivaFoam™ is contraindicated for: 1. Wounds with malignancy except in palliative care 2. Wounds with untreated osteomyelitis 3. Wounds with untreated non-enteric fistula 4. Wounds covered by necrotic tissue 5. Wounds with exposed bone, blood vessels, nerves, organs or 6. anastomotic site 7. Tracheostomy and surgical drains 8. Wounds in patients with known allergies to Polyurethane. 9. For aspiration or suction purposes beyond those specified in the indications for use For detailed Warnings, see the Product IFU.

Primary placement in Sweden; available across 23 countries total.

Trade name

VivaFoam™

UDI-DI code

27350127833034

Basic UDI-DI

B-27350127833034

Reference / catalog number

PDI648303

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

VivaFoam™ is a sterile, single-use, non-antimicrobial wound dressing made of open-cell, reticulated polyurethane foam. It is specifically designed for use as the wound interface layer in NPWT systems. VivaFoam™ is flexible, hydrophobic structure and open-pore architecture designed to: • Facilitate a Moist Wound Healing (MWH) environment. • Conform seamlessly to deep and irregularly shaped wounds. • Ensure even distribution of negative pressure across the wound bed. • Effectively manage exudate by rapidly removing it from the wound. • Promote granulation tissue formation and support the natural healing process.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• MP 48 VivaFoam™ 25x15x1.5

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

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

• M04040601POLYURETHANE DRESSINGS, NON-COMBINED