Organization name

Becton, Dickinson and Company

SRN

US-MF-000019182

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW007

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

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW027

  EUDAMED did not publish a description for this code.
• CW265

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 31 countries total.

Trade name

not provided

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.

30382903673637

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.

038290BDHNKPEPZP

Reference / catalog number

367363

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

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

Status

On the market

Quantity

50

Additional product description

—

Additional information URL

https://eifu.bd.com/

Clinical sizes

• 19 MU50
• Tubing Length = 305 millimetre (mm)
• Needle Gauge = 25 Gauge (G)

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

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

• A01010201BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS

• Class IIa medical devices in EUDAMED

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