Organization name

Bionix LLC

SRN

US-MF-000020408

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• If the DeClogger becomes imbedded in the blockage and cannot be easily dislodged, the enteral feeding tube will need to be changed. DO NOT attempt to physically remove the DeClogger. • Cross-contamination risk. Do not reuse DeCloggers as this may spread contamination from one patient to another patient. • The Bionix DeClogger #913-Green is NOT compatible with ENFit® feeding tube connectors

  OTHER

Primary placement in Belgium; available across 18 countries total.

Trade name

DeClogger

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.

00859911004221

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.

859911004DeCloggerYM

Reference / catalog number

911

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 I

Applicable legislation

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

Status

On the market

Quantity

10

Additional product description

Blue 14-16 DeClogger

Additional information URL

http://www.bionix.com/ifu

Clinical sizes

• 39.5 MU10

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

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

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

• Class I medical devices in EUDAMED

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