41109000L

Organization name

Penta Arzneimittel GmbH

SRN

DE-MF-000006565

Manufacturer status

Active

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

• CW007

  Do not use the product if single dose container is damaged.
• CW032

  Do not use the inhalation solution beyond the expiry date which you can find on each single dose container and on each folding box.
• CW010

  Consult instructions for use.
• CW036

  Do not use Sodium Chloride 3% Inhalation Solution with medicines for inhalation without consulting your doctor.
• CW135

  The eye drops are filled into small plastic containers which could be swallowed by small children. Therefore, please keep the product out of the reach of children. Do not allow children to inhale unsupervised.
• CW011

  Do not use for injection. Do not use if there is a risk of respiratory distress. In individual cases, temporary irritation (e.g. coughing) or a re-sensitive constriction of the bronchial tubes may occur.
• CW129

  Do not use if you are allergic to any of the ingredients.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260595530276

Basic UDI-DI

B-04260595530276

Reference / catalog number

41109000L

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Sodium Chloride 3% Inhalation Solution (single dose container, 4ml) liquifies viscous mucus in the lower respiratory tract by restoring the osmotic balance in the cells.

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

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

• R060203INHALATION THERAPY HUMIDIFICATION LIQUIDS