41089400

Organization name

Penta Arzneimittel GmbH

SRN

DE-MF-000006565

Manufacturer status

Active

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

• 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.
• 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

  Sodium Chloride 0.9 % Inhalation Solution can also be used to dilute medicinal products for inhalation. Before this use, the directions for use of the medicinal product must be carefully read and followed.
• 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.
• CW011

  Do not use for injection.
• 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

14260595531591

Basic UDI-DI

426059553MP09UD01LG

Reference / catalog number

41089400

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 (single dose container, 2.5ml) 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