Sterile injection kits of pharmaceutical specialties

Organization name

Ipsen Pharma Biotech

SRN

FR-MF-000015661

Manufacturer status

Active

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

• CW001

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

  Check the integrity of the packaging before use
• CW009

  Single use
• CW010

  Follow instructions for use carefully
• CW133

  Only use the needles enclosed / Destroy the equipment after use

Primary placement in France; available across 27 countries total.

Trade name

Sterile injection kits of pharmaceutical specialties

UDI-DI code

03582180002540

Basic UDI-DI

B-03582180002540

Reference / catalog number

1037741

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The sterile injection kit is a heat-sealed blister pack in transparent thermoplastic polymer. This blister is closed by a heat-sealed paper operculum and contains the following single use sterile components: • A single-use luer-lock syringe • one IM yellow needle for reconstitution • one IM yellow needle for injection with safety system

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• A0101010101HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS
• A0101010102HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS

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