Cystima Medical D-Man 30 s

Organization name

PK Benelux BV

SRN

NL-MF-000006672

Manufacturer status

Active

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

• CW999

  Warnings: • Do not use when allergic to any of the ingredients; • Adverse effects may occur in overdose, such as flatulence, stomach ache or diarrhoea; • Keep out of reach of young children; • If you experience allergic reactions, stop using Lucovital® D-Mannose sachets. Consult your doctor if: • you discover traces of blood in the urine; • symptoms worsen or persist after 7 days; • you have an existing medical condition or are taking other medication; • you have symptoms of bladder or upper urinary tract infection such as a fever of 38˚C (100.4F) or higher, noncontrollable shivering, nausea (feeling sick), vomiting or diarrhoea. You may suffer from an upper urinary tract infection, which needs additional treatment; • you have a history of kidney stones; • you take blood thinners. Use during pregnancy and/or breastfeeding: There is no data available concerning the use of D-mannose sachets during pregnancy or breastfeeding. Therefore you cannot use this product during pregnancy or breastfeeding. Side effect(s): Lucovital® D-Mannose sachets is well tolerated and has few side effects. Stomach upset or diarrhoea could be a side effect, but is very rare.

Primary placement in Netherlands; available across 1 country total.

Trade name

Cystima Medical D-Man 30 s

UDI-DI code

D-512GMKG

Basic UDI-DI

B-512GMKG

Reference / catalog number

512GM

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

To prevent and support the treatment of urinary tract infections.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

D-512GMKG

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• G0499ORALLY ADMINISTERED GASTROINTESTINAL DEVICES - OTHER