59000300

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 bottle or mouthpiece is damaged.
• CW032

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

  Consult instructions for use.
• CW135

  Keep the medical device out of the reach of children. Do not allow children to inhale unsupervised.
• CW011

  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.
• CW277

  In case a serious incident has occurred during the use of this medical device or as a result of its use, please report it to the manufacturer and the competent authority.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

14260595532871

Basic UDI-DI

426059553MP09SB01KQ

Reference / catalog number

59000300

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Sodium Chloride 0.9% Inhalation Solution (mini inhaler, 10ml) is used for moistening the upper and lower respiratory passages.

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