FTPR101

Trade name

not provided

UDI-DI code

08056300621140

Basic UDI-DI

805630062FTPR101DK

Reference / catalog number

FTPR101

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

ZARBEE’S SYRUP is a medical device composed of substances, not sterile, intended for short term invasive contact with respect to body orifices (oral cavity), designed for the treatment of productive and dry cough in children (2+), adolescents and adults.

Additional information URL

https://labomar.com/en/products/ftpr-101-B/

Clinical sizes

No clinical sizes registered for this device.

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

• V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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

• CW999

  Do not administer the product to children under two years of age. In children aged two years, if symptoms persist and worsen after first two days of treatment, consult your doctor. If you do not notice appreciable results after a short period of treatment (7 days), contact your doctor, in any case do not use for more than 15 days. Do not take it if you are allergic, intolerant or hypersensitive to any component. Do not use the product after the expiry date printed on the package. Keep out of the reach of children. Do not use for purposes other than that for which the product is intended. If you or your child experiences side effects, inform your doctor. Expiry date refers to the product in its intact packaging, and properly stored. Since no data on use in pregnancy and breastfeeding are available, its use is not recommended. If you are pregnant or breastfeeding, consult a doctor before use. Do not use in case the package is not intact. The period of validity after the first opening of the syrup is 3 months. Any serious incident that occurs in relation to the device should be reported to the manufacturer and the Competent Authority. In case of any undesired event always seek for medical advice.

No certificate specifically references this device's Basic UDI-DI.