Organization name

Enable Injections, Inc.

SRN

US-MF-000040157

Manufacturer status

Active

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

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

• CW999

  Not intended to be used with products that need a carefully controlled flow rate.
• CW999

  Not intended to be used on pregnant women.
• CW999

  Not intended to be used with medicinal products that may cause permanent or severe harm requiring medical intervention if it comes into contact with the skin.
• CW010

  EUDAMED did not publish a description for this code.
• CW030

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

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

  EUDAMED did not publish a description for this code.
• CW032

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

  Not intended to be used with lifesaving acute medications.
• CW999

  Not intended for the delivery of blood, blood products, insulin, total parenteral nutrition, and lipid emulsions.
• CW999

  Not intended for patients that have an acrylic allergy.

Primary placement in Netherlands; available across 32 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.

00851869007026

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.

0851869007ENFUSECW

Reference / catalog number

30129910

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

On-Body Delivery System

Additional information URL

https://enableinjections.com/ifu/

Clinical sizes

• 20 MU48
• 0.165 MU50

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

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

• A05010101ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS

• Class IIb medical devices in EUDAMED