PV00025

Organization name

i+Med S.Coop.

SRN

ES-MF-000008633

Manufacturer status

Active

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

• CW009

  Do not reuse, risk of infection
• CW001

  Do not re-sterilize. Re-sterilization can affect the physicochemical properties of the product and compromise its effectiveness and safety.
• CW007

  The product should not be used if the package is damaged or broken.
• CW032

  The product should not be used after the expiration date.
• CW276

  Do not use with other products containing quaternary ammonium salts as benzalkonium chloride or with any surgical material treated with this type of substances because sodium hyaluronate can precipitate in their presence.
• CW036

  Do not administer BtHLINE in immediate association with laser or pulsed light treatments.
• CW135

  BtHLINE should not be administered to children. Keep out of children’s reach.
• CW161

  BtHLINE should not be administered to pregnant or breastfeeding women.
• CW999

  Do not administer BtHLINE to patients with known hypersensitivity (allergy) to hyaluronic acid and / or other components of the product. Do not administer BtHLINE to patients with acute or chronic dermatological disorders or an inflammatory and / or infectious type skin problem. Do not administer BtHLINE to patients with coagulation defects and / or who are treated with anticoagulant medication. BtHLINE should not be injected into blood vessels or eyelids; intravascular injection may produce embolization, occlusion of the vessels, ischemia, blindness or infarction. BtHLINE should be administered exclusively by intradermal injection following a strict aseptic procedure. BtHLINE should be administered with sterile Luer-lock needles (as supplied with the product). It is recommended that the patient do not wear makeup for 12 hours after the injection and avoid prolonged exposure to the sun, to ultraviolet rays, at temperatures below 0°C, as well as the sauna or Turkish bath during two weeks following the injection. The syringe and the used needle should be discarded in a container provided for this purpose.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 11 countries total.

Trade name

not provided

UDI-DI code

08437015992099

Basic UDI-DI

B-08437015992099

Reference / catalog number

PV00025

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC 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

• 1 MU48

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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