VivereX™

Organization name

Sunmedic AB

SRN

SE-MF-000012997

Manufacturer status

Active

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

• CW999

  Contraindication: VivereX(+)™ system 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 anastomotic site 6. Tracheostomy and surgical drains 7. Wounds in patients with known allergies to silicone, nylon or acrylic glue 8. For aspiration or suction purpose 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

VivereX™

UDI-DI code

27350127832242

Basic UDI-DI

B-27350127832242

Reference / catalog number

PDI605224

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

VivereX™ Dressing is medical therapeutic device which manages infiltrate excess wound exudate of a wound through combination of absorption through is superabsorbent layer and vaporization of moisture via cover layer. VivereX™ Dressing is suitable for use at both hospitals and home care settings. Appropriate wound types include: Acute wounds, Chronic wounds with small or medium secretion, Skin grafts or flaps, Pressure ulcers, Diabetic ulcers, surgically clean and closed incisions, Subacute dehisced wounds, Trauma wounds, and Burn injury grade I and II. The VivereX™ dressing manages the wound exudate by two different mechanisms: The absorbent layer of the dressing absorbs some of the secretion. The dressing allows evaporation of the rest of the wound secretion.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• VivereX™ MP FC 16x16

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

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

• M04040702SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES