A0349

Organization name

Tecnoclínic SA

SRN

ES-MF-000000632

Manufacturer status

Active

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

• CW007

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

  - Do not use as a measuring device - Product reuse could cause infection risk - The bag should be substituted before reaching the maximum level - The collection must always be hanged by a support using the pre punched holes, placing it below the urine bladder to avoid reflux - Fix firmly the connector to the prove or penile adaptor - Make sure the drain tap is closed - Be careful not to crush, clamp or collapse the tube while using the product to avoid restricting the flow of the urine into the bag - National regulations for destruction of potentially infectious materials should be observed

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Trade name

not provided

UDI-DI code

18436573680445

Basic UDI-DI

B-18436573680445

Reference / catalog number

A0349

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• A06030301URINE COLLECTION BAGS

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