TPN EVA UV bag Oktatube

Organization name

Eurozyto GmbH

SRN

DE-MF-000008373

Manufacturer status

Active

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

• CW007

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW999

  WARNINGS and CONTRAINDICATIONS Sterility is guaranteed if packaging is intact. Only use if the packaging is undamaged. Dispose of if this is not the case. Inspect the container for any leakage: use only if there is no product loss and if the container is undamaged. Dispose of if this is not the case. Do not use the device for a period of more than 24 hours. DO NOT REUSE and DO NOT RESTERILISE: this product is solely intended for single use. Reuse will affect the performance / sterility of the product with subsequent potential failure / contamination of the product. It is not permitted to sterilise the product a second time.
• CW999

  Please report any severe incidents related to the use of the medical device that occur to Eurozyto GmbH and to the competent authorities. Eurozyto GmbH will not be held responsible under any circumstances for damage caused to the patient when the device is used incorrectly, abnormally, as a result of mishandling or if used by unauthorised personnel.
• CW999

  PRECAUTIONS Do not use the device if packaging is opened or damaged. The device must be used immediately after the sachet is opened. Use only compatible solutions. Please refer to the drug manufacturer’s packaging leaflet for compatible combinations. The device has been tested with saline solution and stored at 2-4°C for 41 days and at 15-25°C on the 42nd day. The use of the device with different solutions and different temperature ranges and storage periods are to take place at the filling centre.

Primary placement in Germany; available across 1 country total.

Trade name

TPN EVA UV bag Oktatube

UDI-DI code

04260738330039

Basic UDI-DI

42607383314001LS

Reference / catalog number

14001339

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

50

Additional product description

MULTICHAMBER PARENTERAL NUTRITION BAGS INTENDED USE Bag used for the preparation and storage of parenteral nutritional solutions before and during administration to patients The device is intended for use by qualified personnel The device may be used on patients of all ages. The medical device has no preventive preclusions for its intended use. Any restrictions are assessed by the doctor or qualified person responsible for its use Product sterilised by irradiation Gamma rays

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2620 MU03

• A080102PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE

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