Organization name

Bioteque Corporation

SRN

TW-MF-000015568

Manufacturer status

Active

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

• Caution

  (1) Do not re-sterile. (2) Single patient use only. (3) Do not use this Closed Suction Catheter more than 72 hours for code ended with D1, D2, and D7; not more than 24 hours for code without D1, D2, and D7. (4) Select the correct size of Closed Suction Catheter. Most experts suggest that the catheter selected should occupy no more than one half of the internal diameter of the artificial airway. (5) Operate appropriate regulated vacuum levels. (6) Operate appropriate suction technique. Always operate caution and well clinical judgment whatever the ventilator mode is in use.

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged

Primary placement in Germany; available across 32 countries total.

Trade name

BIOTEQ

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04712954449823

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-04712954449823

Reference / catalog number

BT-SC5-1654NWFD2

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

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

• 16 MU170
• 54 MU10

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

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

• R050102CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC)

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.